Apparatus with sequentially implanted stimulators

ABSTRACT

A stimulation apparatus for a patient may include an external system configured to transmit transmission signals and an implantable system configured to receive the transmission signals from the external system. The implantable system may include at least one implantable lead, a first implantable device for connecting to the implantable lead during a first time period, and a second implantable device for subsequently connecting to the implantable lead for a second time period.

CROSS REFERENCE

This application is a continuation of U.S. patent application Ser. No.16/539,977, filed Aug. 13, 2019, now U.S. Pat. No. 11,160,980, which isa continuation of PCT Application No. PCT/US2018/019522, filed Feb. 23,2018, which claims priority U.S. Provisional Patent Application No.62/463,328, filed Feb. 24, 2017, the contents of which are incorporatedherein by reference in their entirety for all purposes.

DESCRIPTION OF THE INVENTION Related Applications

This application is related to: U.S. patent application Ser. No.14/424,303, titled “Wireless Implantable Sensing Devices”, filed Feb.26, 2015; U.S. patent application Ser. No. 14/975,358, titled “Methodand Apparatus for Minimally Invasive Implantable Modulators”, filed Dec.18, 2015; U.S. patent application Ser. No. 15/264,864, titled “Methodand Apparatus for Versatile Minimally Invasive Neuromodulators”, filedSep. 14, 2016; U.S. patent application Ser. No. 15/385,729, titled“Method and Apparatus for Neuromodulation Treatments of Pain and OtherConditions”, filed Dec. 20, 2016; International PCT Patent ApplicationSerial Number PCT/US2016/016888, titled “Medical Apparatus Including anImplantable System and an External System”, filed Feb. 5, 2016;International PCT Patent Application Serial Number PCT/US2016/051177,titled “Apparatus for Peripheral or Spinal Stimulation”, filed Sep. 9,2016; International PCT Patent Application Serial NumberPCT/US2017/017978, titled “Apparatus with Enhanced StimulationWaveforms”, filed Feb. 15, 2017; U.S. Provisional Patent ApplicationSer. No. 62/311,297, titled “Devices and Methods for PositioningExternal Devices in Relation to Implanted Devices”, filed Mar. 21, 2016;U.S. Provisional Patent Application Ser. No. 62/341,418, titled “Methodsand Systems for Insertion and Fixation of Implantable Devices”, filedMay 25, 2016; U.S. Provisional Patent Application Ser. No. 62/363,742,titled “Methods and Systems for Treating Pelvic Disorders and PainConditions”, filed Jul. 18, 2016; and U.S. Provisional PatentApplication Ser. No. 62/441,056, titled “Stimulation Apparatus”, filedDec. 30, 2016; the content of each of which is incorporated herein byreference in its entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to a medical apparatus for apatient, and in particular, an apparatus that provides sequentiallyimplanted stimulators that perform both a stimulation trial period aswell as a long-term stimulation therapy.

BACKGROUND OF THE INVENTION

Implantable devices that treat a patient and/or record patient data areknown. For example, implants that deliver energy such as electricalenergy, or deliver agents such as pharmaceutical agents are commerciallyavailable. Implantable electrical stimulators can be used to pace ordefibrillate the heart, as well as modulate nerve tissue (e.g. to treatpain). Most implants are relatively large devices with batteries andlong conduits, such as implantable leads configured to deliverelectrical energy or implantable tubes (i.e. catheters) to deliver anagent. These implants require a fairly invasive implantation procedure,and periodic battery replacement, which requires additional surgery. Thelarge sizes of these devices and their high costs have prevented theiruse in a variety of applications.

Nerve stimulation treatments have shown increasing promise recently,showing potential in the treatment of many chronic diseases includingdrug-resistant hypertension, motility disorders in the intestinalsystem, metabolic disorders arising from diabetes and obesity, and bothchronic and acute pain conditions among others. Many of theseimplantable device configurations have not been developed effectivelybecause of the lack of miniaturization and power efficiency, in additionto other limitations.

There is a need for apparatus, systems, devices and methods that provideone or more implantable devices and are designed to provide enhancedtreatment of pain and other enhanced benefits.

SUMMARY

According to an aspect of the present inventive concepts, a stimulationapparatus for a patient comprises an external system configured totransmit transmission signals and implantable system configured toreceive the transmission signals from the external system. The externalsystem comprises a first external device comprising: at least oneexternal antenna configured to transmit the transmission signals to theimplantable system; an external transmitter configured to drive the atleast one external antenna; an external power supply configured toprovide power to at least the external transmitter; and an externalcontroller configured to control the external transmitter. Theimplantable system comprises: at least one implantable lead forimplanting under the skin of the patient and comprising at least onestimulation element configured to deliver stimulation energy to tissueof the patient, and a first implantable device. The first implantabledevice comprises: at least one implantable antenna configured to receivethe transmission signals from the external system, the transmissionsignal comprising power and data; an implantable receiver configured toreceive the transmission signals from the at least one implantableantenna; a first implantable connector for operably connecting to the atleast one implantable lead; an implantable controller configured todeliver energy to the at least one stimulation element of the at leastone implantable lead, the delivered energy provided by the transmissionsignal received from the external device; and an implantable housingsurrounding at least the implantable controller and the implantablereceiver. The implantable system comprises a second implantable devicecomprising: at least one implantable antenna configured to receive thetransmission signals from the external system, the transmission signalcomprising data; an implantable receiver configured to receive thetransmission signals from the at least one implantable antenna; animplantable energy storage assembly comprising a battery and/or acapacitor; a second implantable connector for operably connecting to theat least one implantable lead; an implantable controller configured todeliver energy to the at least one stimulation element of the at leastone implantable lead, the delivered energy provided by the implantableenergy storage assembly; and an implantable housing surrounding at leastthe implantable controller and the implantable receiver. The firstimplantable device is configured to be attached to the at least oneimplantable lead for a first time period, and the second implantabledevice is configured to be attached to the at least one implantable leadfor a second time period, subsequent to the first time period.

According to another aspect of the present inventive concepts, astimulation apparatus for a patient comprises at least one implantablelead for implanting under the skin of the patient and comprising atleast one stimulation element; an external system comprising: a firstexternal device maintained outside of the patient and configured totransmit power and/or data; and an implantable system comprising: afirst implantable device for implanting under the skin of the patientand configured to receive the power and/or data from the first externaldevice; and a second implantable device for implanting under the skin ofthe patient. The first implantable device is configured to be attachedto the at least one implantable lead for a first time period; and thesecond implantable device is configured to be attached to the at leastone implantable lead for a second time period, subsequent to the firsttime period.

In some embodiments, the at least one implantable device comprises asingle implantable lead, and the first implantable device and the secondimplantable device each attach to the single implantable lead.

In some embodiments, the at least one implantable lead comprises a firstimplantable lead and a second implantable lead, and the firstimplantable device attaches to the first implantable lead and the secondimplantable device attaches to the second implantable lead. The firstimplantable lead can be pre-attached to the first implantable device.The second implantable lead can be pre-attached to the secondimplantable device.

In some embodiments, the apparatus further comprises a filamentextending from the first implantable device housing, and the filamentoperably attaches to the first implantable connector. The apparatus canfurther comprise a fitting which surrounds the filament and the firstimplantable connector.

In some embodiments, the apparatus further comprises a filamentextending from the second implantable device housing, and the filamentoperably attaches to the second implantable connector. The apparatus canfurther comprise a fitting which surrounds the filament and the secondimplantable connector.

In some embodiments, the at least one implantable lead comprises aproximal portion and a distal portion, and the distal portion isdetachable from the proximal portion. The detachable distal portion canbe configured to attach to the second implantable connector. Theproximal portion can be pre-attached to the first implantable device.

In some embodiments, the first implantable device housing comprises aclam-shell design configured to be compressed to operably connect thefirst implantable connector to the at least one implantable lead. Theapparatus can further comprise at least one gasket configured to sealthe first implantable device to the at least one implantable lead.

In some embodiments, the apparatus further comprises a tool configuredto slidingly engage and expand the first implantable connector, afterwhich the at least one implantable lead is inserted into and operablyconnected to the first implantable connector. The tool can be configuredto be removed after the at least one implantable lead is inserted intothe first implantable connector. The apparatus can further comprise atleast one gasket configured to seal the first implantable device to theat least one implantable lead.

In some embodiments, the apparatus further comprises a sleeve configuredto slidingly receive the at least one implantable lead, slidingly engagethe first implantable connector, and operably connect the at least oneimplantable lead to the first implantable connector. The sleeve caninclude multiple connecting segments which connect the at least oneimplantable lead to the first implantable connector. The apparatus canfurther comprise at least one gasket configured to seal the firstimplantable device to the at least one implantable lead. The at leastone gasket can comprise connecting segments which operably connect theat least one implantable lead to the first implantable connector.

In some embodiments, the first implantable connector comprisesfrictionally engaging contacts which operably connect the at least oneimplantable lead to the first implantable connector. The frictionallyengaging contacts can comprise contacts selected from the groupconsisting of: electromechanical brushes; interference connector; cantedsprings; conductive mesh; deformable fingers; and combinations thereof.The apparatus can further comprise at least one gasket configured toseal the first implantable device to the at least one implantable lead.

In some embodiments, the first implantable connector comprises rotatingcontacts which operably connect the at least one implantable lead to thefirst implantable connector. Each rotating contact can comprise a hinge,an extension arm and a conductive pin. Each rotating contact can passthrough the first implantable device housing during rotation. Thehousing can comprise holes through which the rotating contacts passthrough. The apparatus can further comprise at least one gasketconfigured to seal the first implantable device to the at least oneimplantable lead.

In some embodiments, the first implantable connector comprisesspring-loaded contacts which operably connect the at least oneimplantable lead to the first implantable connector. The apparatus canfurther comprise a compression element which compresses the firstimplantable connector around the at least one implantable lead. Theapparatus can further comprise at least one gasket configured to sealthe first implantable device to the at least one implantable lead.

In some embodiments, the first implantable device housing comprises arollable housing configured to circumferentially surround the at leastone implantable lead. The housing can comprise a flexible materialand/or hinged segments.

In some embodiments, the second time period comprises a longer durationthan the first time period.

In some embodiments, the first implantable device is configured toreceive power and data from the external system, and the secondimplantable device is configured to receive data from the externalsystem. The second implantable device does not receive power from theexternal system.

In some embodiments, the first implantable connector and the secondimplantable connector comprise similar construction and arrangement.

In some embodiments, the first implantable connector and the secondimplantable connector comprise dissimilar construction and arrangement.The first implantable connector can be configured to provide acontamination-preventing seal about the at least one implantable leadfor at least a first time period, and the second implantable connectorcan be configured to provide a contamination-preventing seal about theat least one implantable lead for a second time period, and the firsttime period is shorter than the second time period. The first timeperiod can be less than or equal to 3 months. The second time period canbe greater than or equal to 3 months.

In some embodiments, the first implantable device comprises animplantable energy storage assembly. The second implantable deviceenergy storage assembly can have a greater energy storage capacity thanthe first implantable device energy storage assembly. The secondimplantable device energy storage assembly can have at least 10 timesthe energy storage capacity as the energy storage capacity of the firstimplantable device energy storage assembly. The first implantable deviceenergy storage assembly can comprise an energy storage capacity of nomore than 0.6 Joules, no more than 0.7 Joules, and/or no more than 40Joules. The second implantable device energy storage assembly cancomprise an energy storage capacity of at least 60 Joules, at least 700Joules, and/or at least 4,000 Joules.

In some embodiments, the second implantable device energy storageassembly comprises an energy storage capacity of at least 60 Joules, atleast 700 Joules, and/or at least 4,000 Joules.

In some embodiments, the transmission signals comprise a frequencybetween 10 MHz and 10.6 GHz. The transmission signal can comprise afrequency proximate to 40.68 MHz.

In some embodiments, the apparatus is configured to provide thestimulation energy in a waveform with an amplitude between 0.01 mA and15 mA. The apparatus can be configured to provide the stimulation energyin a waveform with an amplitude between 0.01 mA and 10 mA.

In some embodiments, the apparatus is configured to treat hernia pain.At least one of the first implantable device or the second implantabledevice can deliver stimulation at a frequency less than or equal to 1kHz. At least one of the first implantable device or the secondimplantable device can deliver stimulation at a frequency greater thanor equal to 1 kHz. The at least one stimulation element can beconfigured to be positioned proximate nerves and/or their branches. Theat least one stimulation element can be configured to deliversubcutaneous field stimulation. The at least one stimulation element canbe configured to deliver transvascular stimulation.

In some embodiments, the apparatus is configured to treat knee pain. Theat least one stimulation element can be configured to stimulate nervesinnervating the knee and/or tissue surrounding the knee. The at leastone stimulation element can be configured to deliver subcutaneous fieldstimulation. The at least one stimulation element can be configured todeliver transvascular stimulation. The at least one stimulation elementcan be configured to stimulate one or more nerves selected from thegroup consisting of: medial femoral cutaneous and/or infrapatellarcutaneous branches of saphenous nerve; constant articular branches ofcommon peroneal, lateral retinacular nerve; lateral, medial, and/oranterior cutaneous femoral nerve, infrapatellar branch of saphenousnerve, medial and/or lateral retinacular nerve and/or articular branchesof peroneal nerve; obturator, posterior tibial and/or sciatic nerves;tibial nerve; superior, middle and/or inferior genicular nerves; nervesarising from the common peroneal such as the superior lateral, inferiorlateral, and/or recurrent genicular nerves; nerves arising from theobturator nerve such as the genicular branch of obturator; and nervesarising from the femoral nerve such as the saphenous nerve; andcombinations thereof.

In some embodiments, the apparatus is configured to treat carpal tunnelsyndrome. The apparatus can be configured to deliver stimulation totissue selected from the group consisting of: median nerve tissue; ulnarnerve tissue; radial nerve tissue; and combinations thereof.

In some embodiments, least one of the first implantable device or thesecond implantable device comprises a sensor configured to produce asignal correlating to a level of contamination. The sensor can comprisea sensor selected from the group consisting of: pH sensor; opticalsensor; chemical sensor; and combinations thereof. The apparatus can beconfigured to produce an alarm when detected contamination exceeds athreshold.

In some embodiments, the apparatus is configured to treat diabeticneuropathy. The apparatus can be configured to deliver stimulation totibial nerve tissue.

In some embodiments, the apparatus is configured to treat pain. Theapparatus can be configured to treat back pain. The apparatus can beconfigured to treat knee pain.

In some embodiments, the apparatus is configured to treat a type of painselected from the group consisting of: back pain; joint pain;neuropathic pain; tennis elbow; muscle pain; shoulder pain; chronic,intractable pain of the back and/or lower limbs including unilateral orbilateral pain; neuropathic groin pain; perineal pain; phantom limbpain; complex regional pain syndrome; failed back surgery syndrome;cluster headaches; migraines; inflammatory pain; arthritis; abdominalpain; pelvic pain; and combinations thereof.

In some embodiments, the apparatus is configured to treat a pelvicdysfunction. The apparatus can be configured to treat overactivebladder.

In some embodiments, the apparatus is configured to treat a patientdisease or disorder selected from the group consisting of: chronic pain;acute pain; migraine; cluster headaches; urge incontinence; pelvicdysfunction such as overactive bladder; fecal incontinence; boweldisorders; tremor; obsessive compulsive disorder; depression; epilepsy;inflammation; tinnitus; high blood pressure; heart failure; carpaltunnel syndrome; sleep apnea; obstructive sleep apnea; dystonia;interstitial cystitis; gastroparesis; obesity; mobility issues;arrhythmia; rheumatoid arthritis; dementia; Alzheimer's disease; eatingdisorder; addiction; traumatic brain injury; chronic angina; congestiveheart failure; muscle atrophy; inadequate bone growth; post-laminectomypain; liver disease; Crohn's disease; irritable bowel syndrome; erectiledysfunction; kidney disease; and combinations thereof.

In some embodiments, the apparatus is further configured as a diagnosticapparatus. The apparatus can further comprise a sensor configured torecord diagnostic information. The first implantable device and/or thesecond implantable device can comprise the sensor. The first externaldevice can comprise the sensor. The at least one implantable lead cancomprise the sensor.

In some embodiments, the apparatus is configured to deliver stimulationenergy to spinal cord tissue.

In some embodiments, the apparatus is configured to deliver energyselected from the group consisting of: electrical energy; magneticenergy; electromagnetic energy; light energy; infrared light energy,visible light energy; ultraviolet light energy; mechanical energy;thermal energy; heat energy; cryogenic energy; sound energy; ultrasonicsound energy; high intensity focused ultrasound energy; low intensityfocused ultrasound energy; subsonic sound energy; chemical energy; andcombinations thereof.

In some embodiments, the apparatus is configured to randomly varystimulation delivery. The apparatus can be configured to varystimulation based on a probability distribution.

In some embodiments, the apparatus further comprises at least onefunctional element. The at least one functional element can comprise asensor. The first implantable device and/or the second implantabledevice can comprise the sensor. The first external device can comprisethe sensor. The at least one functional element can comprise atransducer. The first implantable device and/or the second implantabledevice can comprise the transducer. The first external device cancomprise the transducer.

According to another aspect of the present inventive concepts, a methodof providing stimulation therapy to a patient comprises (a) providingthe stimulation apparatus according to any claim herein, (b) implantinga first implantable lead and the first implantable device in thepatient, and connecting the first implantable lead to the firstimplantable device; (c) delivering stimulation energy to patient tissuevia the first implantable device for a trial period; (d) detaching thefirst implantable lead from the first implantable device, explanting thefirst implantable device, implanting the second implantable device, andattaching an implantable lead to the second implantable device; and (e)delivering stimulation energy to the patient via the second implantabledevice for a therapy period.

In some embodiments, in step (d) the second implantable device isattached to the first implantable lead.

In some embodiments, the therapy period is of longer duration than thetrial period.

In some embodiments, the trial period comprises a duration of at least 1week.

In some embodiments, the trial period comprises a duration of at least 1month.

In some embodiments, the trial period comprises a duration of at least 2months.

In some embodiments, the trial period comprises a duration of at least 3months.

In some embodiments, the therapy period comprises a duration of at least3 months.

In some embodiments, during step (c), one or more stimulation parametersare varied.

In some embodiments, step (d) comprises detaching a first portion of thefirst implantable lead from a second portion of the first implantablelead.

In some embodiments, the at least one implantable lead comprises adistal portion including the at least one stimulation element and aproximal portion including at least one contact, and the at least onestimulation element and the at least one contact are operably connected.The distal portion can further comprise a flex circuit comprising one ormore traces configured to operably connect the at least one stimulationelement and the at least one contact. The distal portion can furthercomprise a covering surrounding the flex circuit, and the covering cancomprise one or more recesses to expose the at least one stimulationelement. The distal portion can further comprise a conductive rod and alayer stack applied to the conductive rod. The layer stack can comprisealternating layers of an insulator and a conductor, and an outer mostlayer of the layer stack can comprise the insulator. The alternatinglayers of insulator and conductor can be applied using one or more ofthe following deposition processes: sputtering; evaporation; dipping;plating; spraying; and chemical vapor deposition. The layer stack cancomprise one or more recesses to expose a portion of the conductor rodand/or conductor layer, and the exposed portion of the conductor rodand/or conductor layer can comprise the at least one stimulationelement. The conductive rod and/or conductor layer can be configured tooperably connect to the at least one contact.

According to another aspect of the present inventive concepts, a methodof treating a patient disease or disorder comprises providing astimulation apparatus for a patient. The stimulation apparatus cancomprise an implantable system. The implantable system can comprise animplantable lead comprising a distal portion including at least onestimulation element and a proximal portion including at least onecontact, the at least one stimulation element and the at least onecontact can be operably connected, and the at least one stimulationelement can be configured to deliver stimulation energy to tissue of thepatient. The implantable system can comprise an implantable devicecomprising a connector for operably connecting to the at least onecontact of the implantable lead and a controller configured to deliverstimulation energy to the at least contact, and the at least one contactcan be configured to deliver energy to the at least one stimulationelement of the implantable lead. The method can comprise (a) implantingthe implantable lead under the skin of the patient and operablyconnecting the connector of the implantable device to a first contact ofthe implantable lead; (b) delivering a minimum stimulation energy topatient tissue via a first stimulation element; (c) gradually increasingthe minimum stimulation energy to achieve a therapeutic stimulationenergy; (d) decreasing the therapeutic stimulation energy to the minimumstimulation energy; (e) operably disconnecting the connector from thefirst contact and operably connecting the connector to a second contactof the implantable lead; and (f) repeating (b) through (e) withremaining contacts of the implantable lead to achieve a therapeuticstimulation energy with remaining stimulation elements.

In some embodiments, the method further comprises (g) implementing along-term therapy after a therapeutic stimulation energy is achievedwith the final contact and final stimulation element, and the long-termtherapy implements the therapeutic stimulation energy achieved with eachcontact and stimulation element.

According to another aspect of the present inventive concepts, astimulation apparatus for a patient comprising: a first implantabledevice comprising an implantable lead, the implantable lead comprisingat least one contact and at least one stimulation element, and the atleast one contact and the at least one stimulation element are operablyconnected; a second implantable device; and a lead removal toolconfigured to remove the implantable lead from the first implantabledevice. The implantable lead can be configured to operably connect tothe second implantable device once removed from the first implantabledevice.

In some embodiments, the first implantable device comprises a short-termimplantable device.

In some embodiments, the second implantable device comprises a long-termimplantable device.

In some embodiments, the first implantable device and the implantablelead are integrated.

In some embodiments, the implantable lead is fixedly attached to thefirst implantable device during a manufacturing process.

In some embodiments, the first implantable device is operably attachedto the one or more stimulation elements via one or more wires.

In some embodiments, the at least one contact of the implantable leadcomprises an insulating material. The insulating material can comprise apassivation layer applied to the at least one contact. The insulatingmaterial can comprise an insulating sleeve that surrounds the at leastone contact.

The insulating material can extend from a most proximal contact to amost distal contact of the implantable lead. The insulating material canbe configured to be removed from the at least one contact. Theinsulating material can be removed via a peeling process.

In some embodiments, the first implantable device and the implantablelead are operably attached via a connector.

In some embodiments, the lead removal tool comprises an opening, and theopening is configured to slidingly receive the first implantable device.The opening can comprise one or more projections, and the one or moreprojections can be configured to engage the implantable lead. The one ormore projections can be configured to engage a proximal portion of theimplantable lead. The one or more projections can be configured toengage the implantable lead at pre-determined location, and thepre-determined location can comprise a marker positioned on theimplantable lead. The marker can be positioned at weakened portion ofthe implantable lead. The one or more projections can be configured totravel inward and frictionally engage the implantable lead in responseto an external force. The one or more projections can cause a break inthe implantable lead, and the implantable lead can be separated from thefirst implantable device.

In some embodiments, the second stimulation device can slidingly receiveand operably engage the at least one contact of the implantable lead.

In some embodiments, the apparatus further comprises a lead attachmentassembly. The lead attachment assembly can comprise an attachmentmechanism configured to attach an implantable lead to a stimulationdevice. The attachment mechanism can comprise a base portion comprisingone or more contacts operably connected to a conduit and one or morehinged portions. The one or more hinged portions can comprise a firstrecess configured to slidingly receive at least a portion of theimplantable lead. The one or more contacts of the base portion can beconfigured to extend into the first recess and operably connect to oneor more contacts of the implantable lead.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of embodimentsof the present inventive concepts will be apparent from the moreparticular description of preferred embodiments, as illustrated in theaccompanying drawings in which like reference characters refer to thesame or like elements. The drawings are not necessarily to scale,emphasis instead being placed upon illustrating the principles of thepreferred embodiments.

FIG. 1 is a schematic view of a medical apparatus comprising an externalsystem and two implantable systems, consistent with the presentinventive concepts.

FIG. 1A is a schematic view of an implantable device comprising anextending conduit for attachment to a lead, consistent with the presentinventive concepts.

FIG. 1B is a schematic view of an implantable device comprising anextending conduit for attachment to a lead and a contamination-limitingfitting, consistent with the present inventive concepts.

FIG. 1C is a schematic view of two implantable devices, the firstimplantable device comprising a pre-attached lead, the lead comprising aremovable portion, consistent with the present inventive concepts.

FIG. 2 is a flow chart of a method of providing stimulation for aninitial trial period, and a subsequent therapy period, consistent withthe present inventive concepts.

FIG. 3 is a perspective view of an apparatus comprising a temporaryimplantable device and an attachable lead for use in a trialing period,consistent with the present inventive concepts.

FIGS. 4A-B are top views of an apparatus comprising a temporaryimplantable device and an attachment lead for use in a trialing period,consistent with the present inventive concepts.

FIGS. 5A-B are top views of an apparatus comprising a temporaryimplantable device and an attachment lead for use in a trialing period,consistent with the present inventive concepts.

FIGS. 6A-C are a side view, a sectional view, and a perspective view,respectively, of an attachment port of an implantable device, consistentwith the present inventive concepts.

FIGS. 7A-C are a side sectional view, a sectional view, and aperspective view, respectively, of an attachment port of an implantabledevice consistent with the present inventive concepts.

FIGS. 8A-C are a side view, a sectional view, and a perspective view,respectively, of an attachment port of an implantable device, consistentwith the present inventive concepts.

FIG. 9A-B are a side sectional view, and an end view, respectively, ofan implantable device, consistent with the present inventive concepts.

FIG. 10A-B are perspective views of an implantable device prior to andafter attachment to a lead, respectively, the implantable devicecomprising a rollable construction for surrounding the lead, consistentwith the present inventive concepts.

FIGS. 11A-D are perspective views of various embodiments of a distalportion of a stimulation lead, consistent with the present inventiveconcepts.

FIGS. 12A-C are side views of various embodiments of a proximal portionof a stimulation lead, consistent with the present inventive concepts.

FIG. 13 is a flow chart of a method of providing stimulation during atrailing procedure, consistent with the present inventive concepts.

FIGS. 14A-D are side views of an implantable system comprising ashort-term (temporary) implantable device with an integrated lead, and alead removal tool, consistent with the present inventive concepts.

FIGS. 15A-E a perspective view of a stimulator and a lead attachmentassembly, and various close-up views of an attachment mechanism of theattachment assembly, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS

The terminology used herein is for the purpose of describing particularembodiments and is not intended to be limiting of the inventiveconcepts. Furthermore, embodiments of the present inventive concepts mayinclude several novel features, no single one of which is solelyresponsible for its desirable attributes or which is essential topracticing an inventive concept described herein. As used herein, thesingular forms “a,” “an” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise.

It will be further understood that the words “comprising” (and any formof comprising, such as “comprise” and “comprises”), “having” (and anyform of having, such as “have” and “has”), “including” (and any form ofincluding, such as “includes” and “include”) or “containing” (and anyform of containing, such as “contains” and “contain”) when used herein,specify the presence of stated features, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, integers, steps, operations,elements, components, and/or groups thereof.

It will be understood that, although the terms first, second, third etc.may be used herein to describe various limitations, elements,components, regions, layers, and/or sections, these limitations,elements, components, regions, layers, and/or sections should not belimited by these terms. These terms are only used to distinguish onelimitation, element, component, region, layer or section from anotherlimitation, element, component, region, layer or section. Thus, a firstlimitation, element, component, region, layer or section discussed belowcould be termed a second limitation, element, component, region, layeror section without departing from the teachings of the presentapplication.

It will be further understood that when an element is referred to asbeing “on”, “attached”, “connected” or “coupled” to another element, itcan be directly on or above, or connected or coupled to, the otherelement, or one or more intervening elements can be present. Incontrast, when an element is referred to as being “directly on”,“directly attached”, “directly connected” or “directly coupled” toanother element, there are no intervening elements present. Other wordsused to describe the relationship between elements should be interpretedin a like fashion (e.g. “between” versus “directly between,” “adjacent”versus “directly adjacent,” etc.). A first component (e.g. a device,assembly, housing or other component) can be “attached”, “connected” or“coupled” to another component via a connecting filament (as definedbelow). In some embodiments, an assembly comprising multiple componentsconnected by one or more connecting filaments is created during amanufacturing process (e.g. pre-connected at the time of an implantationprocedure of the system of the present inventive concepts).Alternatively or additionally, a connecting filament can comprise one ormore connectors (e.g. a connectorized filament comprising a connector onone or both ends), and a similar assembly can be created by a user (e.g.a clinician) operably attaching the one or more connectors of theconnecting filament to one or more mating connectors of one or morecomponents of the assembly.

It will be further understood that when a first element is referred toas being “in”, “on” and/or “within” a second element, the first elementcan be positioned: within an internal space of the second element,within a portion of the second element (e.g. within a wall of the secondelement); positioned on an external and/or internal surface of thesecond element; and combinations of one or more of these.

Spatially relative terms, such as “beneath,” “below,” “lower,” “above,”“upper” and the like may be used to describe an element and/or feature'srelationship to another element(s) and/or feature(s) as, for example,illustrated in the figures. It will be understood that the spatiallyrelative terms are intended to encompass different orientations of thedevice in use and/or operation in addition to the orientation depictedin the figures. For example, if the device in a figure is turned over,elements described as “below” and/or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.The device can be otherwise oriented (e.g. rotated 90 degrees or atother orientations) and the spatially relative descriptors used hereininterpreted accordingly.

The term “and/or” where used herein is to be taken as specificdisclosure of each of the two specified features or components with orwithout the other. For example “A and/or B” is to be taken as specificdisclosure of each of (i) A, (ii) B and (iii) A and B, just as if eachis set out individually herein.

The term “diameter” where used herein to describe a non-circulargeometry is to be taken as the diameter of a hypothetical circleapproximating the geometry being described. For example, when describinga cross section, such as the cross section of a component, the term“diameter” shall be taken to represent the diameter of a hypotheticalcircle with the same cross sectional area as the cross section of thecomponent being described.

The terms “major axis” and “minor axis” of a component where used hereinare the length and diameter, respectively, of the smallest volumehypothetical cylinder which can completely surround the component.

The term “functional element” where used herein, is the be taken toinclude a component comprising one, two or more of: a sensor; atransducer; an electrode; an energy delivery element; an agent deliveryelement; a magnetic field generating transducer; and combinations of oneor more of these. In some embodiments, a functional element comprises atransducer selected from the group consisting of: light deliveryelement; light emitting diode; wireless transmitter; Bluetooth device;mechanical transducer; piezoelectric transducer; pressure transducer;temperature transducer; humidity transducer; vibrational transducer;audio transducer; speaker; and combinations of one or more of these. Insome embodiments, a functional element comprises a needle, a catheter(e.g. a distal portion of a catheter), an iontophoretic element or aporous membrane, such as an agent delivery element configured to deliverone or more agents. In some embodiments, a functional element comprisesone or more sensors selected from the group consisting of: electrode;sensor configured to record electrical activity of tissue; blood glucosesensor such as an optical blood glucose sensor; pressure sensor; bloodpressure sensor; heart rate sensor; inflammation sensor; neural activitysensor; muscular activity sensor; pH sensor; strain gauge;accelerometer; gyroscope; GPS; respiration sensor; respiration ratesensor; temperature sensor; magnetic sensor; optical sensor; MEMssensor; chemical sensor; hormone sensor; impedance sensor; tissueimpedance sensor; body position sensor; body motion sensor; physicalactivity level sensor; perspiration sensor; patient hydration sensor;breath monitoring sensor; sleep monitoring sensor; food intakemonitoring sensor; urine movement sensor; bowel movement sensor; tremorsensor; pain level sensor; orientation sensor; motion sensor; andcombinations of one or more of these.

The term “transducer” where used herein is to be taken to include anycomponent or combination of components that receives energy or anyinput, and produces an output. For example, a transducer can include anelectrode that receives electrical energy, and distributes theelectrical energy to tissue (e.g. based on the size of the electrode).In some configurations, a transducer converts an electrical signal intoany output, such as light (e.g. a transducer comprising a light emittingdiode or light bulb), sound (e.g. a transducer comprising a piezocrystal configured to deliver ultrasound energy), pressure, heat energy,cryogenic energy, chemical energy; mechanical energy (e.g. a transducercomprising a motor or a solenoid), magnetic energy, and/or a differentelectrical signal (e.g. a Bluetooth or other wireless communicationelement). Alternatively or additionally, a transducer can convert aphysical quantity (e.g. variations in a physical quantity) into anelectrical signal. A transducer can include any component that deliversenergy and/or an agent to tissue, such as a transducer configured todeliver one or more of: electrical energy to tissue (e.g. a transducercomprising one or more electrodes); light energy to tissue (e.g. atransducer comprising a laser, light emitting diode and/or opticalcomponent such as a lens or prism); mechanical energy to tissue (e.g. atransducer comprising a tissue manipulating element); sound energy totissue (e.g. a transducer comprising a piezo crystal); thermal energy totissue (e.g. heat energy and/or cryogenic energy); chemical energy;electromagnetic energy; magnetic energy; and combinations of one or moreof these.

The term “transmission signal” where used herein is to be taken toinclude any signal transmitted between two components, such as via awired or wireless communication pathway. For example, a transmissionsignal can comprise a power and/or data signal wirelessly transmittedbetween a component external to the patient and one or more componentsimplanted in the patient. A transmission signal can include one or moresignals transmitted using body conduction. Alternatively oradditionally, a transmission signal can comprise reflected energy, suchas energy reflected from any power and/or data signal.

The term “data signal” where used herein is to be taken to include atransmission signal including at least data. For example, a data signalcan comprise a transmission signal including data and sent between acomponent external to the patient and one or more components implantedin the patient. Alternatively, a data signal can comprise a transmissionsignal including data sent from an implanted component to one or morecomponents external to the patient. A data signal can comprise aradiofrequency signal including data (e.g. a radiofrequency signalincluding both power and data) and/or a data signal sent using bodyconduction.

The term “implantable” where used herein is to be taken to define acomponent which is constructed and arranged to be fully or partiallyimplanted in a patient's body and/or a component that has been fully orpartially implanted in a patient. The term “external” where used hereinis to be taken to define a component which is constructed and arrangedto be positioned outside of the patient's body.

The terms “connection”, “connected”, “connecting” and the like, whereused herein, are to be taken to include any type of connection betweentwo or more components. The connection can include an operableconnection which allows multiple connected components to operatetogether such as to transfer information, power and/or material (e.g. anagent to be delivered) between the components. An operable connectioncan include a physical connection, such as a physical connectionincluding one or more wires, optical fibers, wave guides, tubes such asfluid transport tubes and/or linkages such as translatable rods or othermechanical linkages. Alternatively or additionally, an operableconnection can include a non-physical or “wireless” connection, such asa wireless connection in which information and/or power is transmittedbetween components using electromagnetic energy. A connection caninclude a connection selected from the group consisting of: a wiredconnection; a wireless connection; an electrical connection; amechanical connection; an optical connection; a sound propagatingconnection; a fluid connection; and combinations of one or more ofthese.

The term “connecting filament” where used herein is to be taken todefine a filament connecting a first component to a second component.The connecting filament can include a connector on one or both ends,such as to allow a user to operably attach at least one end of thefilament to a component. A connecting filament can comprise one or moreelements selected from the group consisting of: wires; optical fibers;fluid transport tubes; mechanical linkages; wave guides; flexiblecircuits; and combinations of one or more of these. A connectingfilament can comprise rigid filament, a flexible filament or it cancomprise one or more flexible portions and one or more rigid portions.

The term “connectorized” where used herein is to be taken to refer to afilament, housing or other component that includes one or moreconnectors (e.g. clinician or other user-attachable connectors) foroperably connecting that component to a mating connector (e.g. of thesame or different component).

The terms “stimulation parameter”, “stimulation signal parameter” or“stimulation waveform parameter” where used herein can be taken to referto one or more parameters of a stimulation waveform (also referred to asa stimulation signal). Applicable stimulation parameters of the presentinventive concepts shall include but are not limited to: amplitude (e.g.amplitude of voltage and/or current); average amplitude; peak amplitude;frequency; average frequency; period; phase; polarity; pulse shape; aduty cycle parameter (e.g. frequency, pulse width, and/or off time);inter-pulse gap; polarity; burst-on period; burst-off period;inter-burst period; pulse train; train-on period; train-off period;inter-train period; drive impedance; duration of pulse and/or amplitudelevel; duration of stimulation waveform; repetition of stimulationwaveform; an amplitude modulation parameter; a frequency modulationparameter; a burst parameter; a power spectral density parameter; ananode/cathode configuration parameter; amount of energy and/or power tobe delivered; rate of energy and/or power delivery; time of energydelivery initiation; method of charge recovery; and combinations of oneor more of these. A stimulation parameter can refer to a singlestimulation pulse, multiple stimulation pulses, or a portion of astimulation pulse. The term “amplitude” where used herein can refer toan instantaneous or continuous amplitude of one or more stimulationpulses (e.g. the instantaneous voltage level or current level of apulse). The term “pulse” where used herein can refer to a period of timeduring which stimulation energy is relatively continuously beingdelivered. In some embodiments, stimulation energy delivered during apulse comprises energy selected from the group consisting of: electricalenergy; magnetic energy; electromagnetic energy; light energy; soundenergy such as ultrasound energy; mechanical energy such as vibrationalenergy; thermal energy such as heat energy or cryogenic energy; chemicalenergy; and combinations of one or more of these. In some embodiments,stimulation energy comprises electrical energy and a pulse comprises aphase change in current and/or voltage. In these embodiments, aninter-phase gap can be present within a single pulse. The term“quiescent period” where used herein can refer to a period of timeduring which zero energy or minimal energy is delivered (e.g.insufficient energy to elicit an action potential and/or other neuronalresponse). The term “inter-pulse gap” where used herein can refer to aquiescent period between the end of one pulse to the onset of the next(sequential) pulse. The terms “pulse train” or “train” where used hereincan refer to a series of pulses. The terms “burst”, “burst of pulses” or“burst stimulation” where used herein can refer to a series of pulsetrains, each separated by a quiescent period. The term “train-on period”where used herein can refer to a period of time from the beginning ofthe first pulse to the end of the last pulse of a single train. The term“train-off period” where used herein can refer to a quiescent periodbetween the end of one train and the beginning of the next train. Theterm “burst-on period” where used herein can refer to a period of timefrom the beginning of the first pulse of the first train to the end ofthe last pulse of the last train of a single burst. The term “burst-offperiod” where used herein can refer to a quiescent period between theend of one burst and the beginning of the next burst. The term“inter-train period” where used herein can refer to a quiescent periodbetween the end of one train and the beginning of the next train. Theterm “inter-burst period” where used herein can refer to a quiescentperiod between the end of one burst and the beginning of the next burst.The term “train envelope” where used herein can refer to a curveoutlining the amplitude extremes of a series of pulses in a train. Theterm “burst envelope” where used herein can refer to a curve outliningthe amplitude extremes of a series of pulses in a burst. The term “trainramp duration” where used herein can refer to the time from the onset ofa train until its train envelope reaches a desired target magnitude. Theterm “burst ramp duration” where used herein can refer to the time fromthe onset of a burst until its burst envelope reaches a desired targetmagnitude.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub-combination. For example, it will be appreciated thatall features set out in any of the claims (whether independent ordependent) can be combined in any given way.

The present inventive concepts include a medical apparatus and clinicalmethods for treating a patient, such as to treat pain. The patient cancomprise a human or other mammalian patient. The medical apparatus cancomprise a stimulation apparatus. The medical apparatus can comprise animplantable system and an external system. The implantable system cancomprise one or more similar and/or dissimilar implantable devices. Insome embodiments, the implantable system comprises a first implantabledevice that delivers stimulation energy via energy received wirelesslyfrom one or more external devices, and a second implantable device thatdelivers stimulation energy via an integral (e.g. implanted) battery. Inthese embodiments, the first implantable device can be configured todeliver stimulation energy during a limited period of time (e.g. a trialperiod in which stimulation settings are determined and/or acceptabilityof the apparatus is determined), and the second implantable device canbe configured to deliver stimulation energy for a prolonged period oftime in which long-term stimulation therapy is provided to a patient. Inthese embodiments, a single implantable lead comprising one or morestimulation energy delivery elements (e.g. electrodes) can be connectedto the first implantable device and then the second implantable device.In some embodiments, a first implantable device can be configured toremain implanted in the patient for a limited period of time, such as toreduce cost of manufacture, and a second implantable device isconfigured for a longer implant life. The first implantable device canbe used in a trialing procedure in which the stimulation apparatus isassessed for acceptable use (e.g. by the patient and/or clinician)and/or one or more stimulation settings are optimized or otherwisedetermined.

Each implantable device can comprise one or more implantable antennasconfigured to receive power and/or data. In some embodiments, a firstimplantable device receives power and data, and a second implantabledevice receives data (e.g. without receiving power). Each implantabledevice can comprise an implantable receiver configured to receive thepower and/or data from the one or more implantable antennas. Eachimplantable device can comprise one or more implantable functionalelements. An implantable functional element can be configured tointerface with the patient (e.g. interface with tissue of the patient orinterface with any patient location). Alternatively or additionally, animplantable functional element can interface with a portion of animplantable device (e.g. to measure an implantable device parameter). Insome embodiments, the one or more implantable functional elements cancomprise one or more transducers, electrodes, and/or other elementsconfigured to deliver energy to tissue. Alternatively or additionally,the one or more implantable functional elements can comprise one or moresensors, such as a sensor configured to record a physiologic parameterof the patient. In some embodiments, one or more implantable functionalelements are configured to record device information and/or patientinformation (e.g. patient physiologic or patient environmentinformation).

Each implantable device can comprise an implantable controllerconfigured to control (e.g. modulate power to, send a signal to and/orreceive a signal from) the one or more implantable functional elements.In some embodiments, an implantable controller of a first implantabledevice is configured to control one or more other implantable devices.Each implantable device can comprise an implantable energy storageassembly (e.g. a battery and/or a capacitor) configured to provide powerto the implantable controller (e.g. a controller comprising astimulation waveform generator), the implantable receiver and/or the oneor more implantable functional elements. In some embodiments, animplantable energy storage assembly is further configured to providepower to an assembly that transmits signals via the implantable antenna(e.g. when the implantable device is further configured to transmit datato one or more external devices). Each implantable device can comprisean implantable housing surrounding the implantable controller and theimplantable receiver. In some embodiments, one or more implantableantennas are positioned within the implantable housing. Alternatively oradditionally, one or more implantable antennas and/or implantablefunctional elements can be tethered (e.g. electrically tethered) to theimplantable housing. In some embodiments, one or more implantablefunctional elements are positioned on an implantable lead, such as aflexible lead mechanically fixed or attachable to the implantablehousing and operably connected (e.g. electrically, fluidly, optically,and/or mechanically) to one or more components internal to theimplantable housing. The implantable lead can be inserted (e.g.tunneled) through tissue of the patient, such that its one or morefunctional elements are positioned proximate tissue to be treated and/orpositioned at an area in which data is to be recorded. In someembodiments, the implantable lead is configured to operably attach toand/or detach from, multiple implantable devices.

The external system of the medical apparatus of the present inventiveconcepts can comprise one or more similar and/or dissimilar externaldevices. Each external device can comprise one or more external antennasconfigured to transmit power and/or data to one or more implantedcomponents of the implantable system. Each external device can comprisean external transmitter configured to drive the one or more externalantennas. Each external device can comprise an external power supplyconfigured to provide power to at least the external transmitter. Eachexternal device can comprise an external programmer configured tocontrol the external transmitter and/or an implantable device (e.g. whenan external power transmitter is not included in the apparatus orotherwise not present during use). Each external device can comprise anexternal housing that surrounds at least the external transmitter. Insome embodiments, the external housing surrounds the one or moreexternal antennas, the external power supply and/or the externalprogrammer.

The external programmer can comprise a discrete controller separate fromthe one or more external devices, and/or a controller integrated intoone or more external devices. The external programmer can comprise auser interface, such as a user interface configured to set and/or modifyone or more treatment and/or data recording settings of the medicalapparatus of the present inventive concepts. In some embodiments, theexternal programmer is configured to provide control signals to one ormore external devices (e.g. one or more external devices that provide atleast power to a first implantable device), and to provide controlsignals to an implantable device (e.g. a second implantable device thatdoes not receive power from an external device). In some embodiments,the external programmer can be configured to collect and/or diagnoserecorded patient information, such as to provide the information and/ordiagnosis to a clinician of the patient, to a patient family memberand/or to the patient themselves. The collected information and/ordiagnosis can be used to adjust treatment or other operating parametersof the medical apparatus.

In some embodiments, a medical apparatus comprises a stimulationapparatus for activating, blocking, affecting or otherwise stimulating(hereinafter “stimulate” or “stimulating”) tissue of a patient, such asnerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nervetissue” or “nervous system tissue”). The stimulation apparatus comprisesan external system configured to transmit power, and an implanted systemcomprising at least one implantable device configured to receive thepower from the external system and to deliver stimulation energy totissue. The implantable system can further comprise one or moreadditional implantable devices that do not receive power from theexternal system (e.g. implantable devices that have an internal batteryor other power source that provides the stimulation energy). Thedelivered stimulation energy can comprise one or more stimulationwaveforms, such as a stimulation waveform configured to enhancetreatment of pain while minimizing undesired effects. The stimulationsignal (also referred to as “stimulation energy” herein) delivered bythe implanted system can be independent of the power received from theexternal system, such as to be independent of one or more of: theposition of one or more components of the external system; the changingposition of one or more components of the external system; the frequencyof the power received from the external system; the amplitude of thepower received from the external system; changes in amplitude of thepower received from the external system; duty cycle of the powerreceived from the external system; envelope of the power received fromthe external system; and combinations of one or more of these.

Referring now to FIG. 1 , a schematic view of a stimulation apparatusfor providing a therapy to a patient is illustrated, consistent with thepresent inventive concepts. Apparatus 10 comprises implantable system 20and external system 50. External system 50 transmits transmissionsignals to one or more components of implantable system 20. Thesetransmission signals can comprise power and/or data. Implantable system20 comprises implantable device 200 which is configured to be implantedbeneath the skin of a patient. In some embodiments, implantable system20 comprises multiple similar or dissimilar implantable devices 200(singly or collectively implantable device 200), such as is described inapplicant's co-pending application International PCT Patent ApplicationSerial Number PCT/US2017/017978, titled “Apparatus with EnhancedStimulation Waveforms”, filed Feb. 15, 2017, the content of which isincorporated herein in its entirety for all purposes. Each implantabledevice 200 can be configured to receive power and data from atransmission signal transmitted by external system 50, such as whenstimulation energy delivered to the patient (e.g. to nerve or othertissue of the patient) by implantable device 200 is provided viawireless transmissions signals from external system 50. In someembodiments, implantable system 20 further comprises a secondimplantable device, implantable device 800 shown, also configured to beimplanted beneath the skin of the patient. In these embodiments,implantable device 800 can provide one or more implantable devices thatdeliver stimulation energy to the patient without receiving power fromexternal system 50, such as when power is (primarily) provided from apower source internal to implantable device 800 (e.g. energy storageassembly 870 shown or other energy storage element of implantable device800). While not receiving power, implantable device 800 can receive data(e.g. stimulation parameters or other programming data) from externalsystem 50.

Implantable system 20 can comprise one or more implantable leads, suchas implantable lead 265 shown. Lead 265 comprises one or morestimulation elements (e.g. one or more electrodes or other energydelivering elements as described herein), stimulation element 260 (threeshown in FIG. 1 ). Alternatively or additionally, one or morestimulation elements 260 can be positioned on housing 210 of implantabledevice 200 and/or housing 810 of implantable device 800, for examplewhen current is delivered in a monopolar mode (e.g. current deliveredbetween a stimulation element 260 on lead 265 and a stimulation element260 on housing 210 and/or 810). Implantable device 200 is configured tooperably connect (e.g. electrically, optically, acoustically and/orotherwise operably connect) to lead 265, via its implantable connector,attachment port 290, such as via a connection performed by a clinicianduring a surgical procedure in which one or more components ofimplantable system 20 are implanted in the patient. Implantable device800 is also configured to operably connect to lead 265 (e.g. the samelead 265 or a newly implanted lead 265), via its implantable connector,attachment port 890. Attachment ports 290 and 890 can be of similar ordissimilar construction. For example, attachment port 290 can beconstructed and arranged to provide a contamination-preventing seal withlead 265 for a limited time period (e.g. less than 3 months), whileattachment port 890 can be constructed and arranged to provide acontamination-preventing seal with lead 265 for an extended time period(e.g. at least 3 months, at least 1 year, or at least 2 years). In someembodiments, implantable device 200 is configured to disconnect fromlead 265 (e.g. in a second clinical procedure performed after theimplantable device 200 implantation procedure), such that implantabledevice 800 can subsequently be connected to the same lead 265, such asis described herebelow in reference to FIG. 2 . In these embodiments,implantable device 200 can be configured to be implanted in the patientto conduct a trial procedure via lead 265 (e.g. as described herebelowin reference to FIG. 2 ) for a trial period, after which implantabledevice 800 is implanted to provide stimulation therapy to the patientfor a therapy period, such as via the same, previously implanted lead265.

External system 50 can comprise an external device 500, which includeshousing 510. In some embodiments, external system 50 comprises multipleexternal devices 500 (singly or collectively external device 500), alsoas is described in applicant's co-pending application International PCTPatent Application Serial Number PCT/US2017/017978, titled “Apparatuswith Enhanced Stimulation Waveforms”, filed Feb. 15, 2017. Each externaldevice 500 can be configured to transmit transmission signals that sendpower and/or data to one or more components of implantable system 20,such as implantable device 200. Alternatively or additionally, externalsystem 50 can comprise external programmer, programmer 550, which cancomprise a user interface, such as user interface 555. Programmer 550can be configured to transmit transmission signals that send data to:one or more external devices 500, one or more implantable devices 200,and/or one or more implantable devices 800, such as to adjust thesettings of or otherwise control these components of apparatus 10.External programmer 550 can comprise housing (housing 551), atransmitting element (transmitter 553), a battery or other power supply(power supply 557), and one or more antennas (antenna 540 a).

Apparatus 10 can be configured to stimulate tissue (e.g. stimulate nervetissue such as tissue of the central nervous system or tissue of theperipheral nervous system, such as to neuromodulate nerve tissue), suchas by having one or more implantable devices 200 and/or implantabledevices 800 deliver energy to one or more tissue locations. In someembodiments, one or more implantable devices 200 deliver energy (e.g.continuously or intermittently) to the patient while simultaneously, orrelatively simultaneously (e.g. power received from external system 50within 60 seconds, within 5 minutes and/or within 15 minutes ofstimulation delivery, “simultaneously” herein) receiving power from oneor more external devices 500. In some embodiments, one or moreimplantable devices 800 deliver energy (e.g. continuously orintermittently) to the patient, where the energy is provided by aninternal power source (e.g. a battery and/or capacitor, such as energystorage assembly 870 shown) without receiving externally supplied power.For example, implantable device 800 may not receive power from anyexternal device for a time period of at least 1 hour, at least 1 day, atleast 1 month or at least 1 year, while delivering stimulation energyduring those same time periods. During those time periods of no energybeing provided from an external source, one or more stimulationparameters of implantable device 800 can be varied during those periods,such as a variation based on data sent by programmer 550, an externaldevice 500 and/or other external component of apparatus 10.

In some embodiments, apparatus 10 is further configured as a patientdiagnostic apparatus, such as by having one or more implantable devices200, one or more implantable devices 800, and/or one or more externaldevices 500 record a patient parameter (e.g. a patient physiologicparameter) from one or more tissue locations. In some embodiments,during its use, one or more implantable devices 200 at least receivespower from one or more external devices 500 (e.g. with or without alsoreceiving data).

Alternatively or additionally, apparatus 10 can be configured as apatient information recording apparatus, such as by having one or moreimplantable devices 200, one or more implantable devices 800, and/or oneor more external devices 500 record patient information (e.g. patientphysiologic information and/or patient environment information). In someembodiments, one or more implantable devices 200, one or moreimplantable devices 800, and/or one or more external devices 500 furthercollect information (e.g. status information or configuration settings)of one or more of the components of apparatus 10.

In some embodiments, apparatus 10 is configured to deliver stimulationenergy to tissue to treat pain. In particular, apparatus 10 can beconfigured to deliver stimulation energy to tissue of the spinal cordand/or tissue associated with the spinal cord (“tissue of the spinalcord”, “spinal cord tissue” or “spinal cord” herein), the tissueincluding roots, dorsal root, dorsal root ganglia, spinal nerves,ganglia, and/or other nerve tissue. The delivered energy can compriseenergy selected from the group consisting of: electrical energy;magnetic energy; electromagnetic energy; light energy such as infraredlight energy, visible light energy, and/or ultraviolet light energy;mechanical energy; thermal energy such as heat energy and/or cryogenicenergy; sound energy such as ultrasonic sound energy (e.g. highintensity focused ultrasound and/or low intensity focused ultrasound)and/or subsonic sound energy; chemical energy; and combinations of oneor more of these. In some embodiments, apparatus 10 is configured todeliver energy to tissue in a form selected from the group consistingof: electrical energy such as by providing a controlled (e.g. constantor otherwise controlled) electrical current and/or voltage to tissue;magnetic energy (e.g. magnetic field energy) such as by applyingcontrolled current or voltage to a coil or other magnetic fieldgenerating element positioned proximate tissue; and/or electromagneticenergy such as by providing both current to tissue and a magnetic fieldto tissue. The coil or other magnetic field generating element cansurround (e.g. at least partially surround) the target nerve and/or itcan be incorporated as part of an anchoring system to the target tissue.Alternatively, or additionally, the magnetic energy can be appliedexternally and focused to specific target tissue via an implantcomprising a coil and/or ferromagnetic materials. In some embodiments,the magnetic energy is configured to induce the application ofmechanical energy. Delivered energy can be supplied in one or morestimulation waveforms, each waveform comprising one or more pulses ofenergy, as described in detail herebelow.

In some embodiments, apparatus 10 is configured as a stimulationapparatus in which external system 50 transmits a power signal to one ormore implantable devices 200, and the one or more implantable devices200 delivers stimulation energy to tissue with a stimulation signal(also referred to as a stimulation waveform), with the power signal andthe stimulation signal having one or more different characteristics. Thepower signal can further be modulated with data (e.g. configuration orother data to be sent to one or more implantable devices 200). In theseembodiments, the characteristics of the stimulation signal delivered(e.g. amplitude, frequency, duty cycle, and/or pulse width), can beindependent (e.g. partially or completely independent) of thecharacteristics of the power signal transmission (e.g. amplitude,frequency, phase, envelope, duty cycle, and/or modulation). For example,the frequency and modulation of the power signal can change withoutaffecting the stimulation signal, or the stimulation signal can bechanged (e.g. via programmer 550), without requiring the power signal tochange. In some embodiments, implantable system 20 can be configured torectify the power signal, and produce a stimulation waveform withentirely different characteristics (e.g. amplitude, frequency, and/orduty cycle) from the rectified power signal. Each implantable device 200can comprise an oscillator and/or controller configured to produce thestimulation signal. In some embodiments, one or more implantable devices200 is configured to perform frequency multiplication, in which multiplesignals are multiplexed, mixed, added, and/or combined in other ways toproduce a broadband stimulation signal.

In some embodiments, apparatus 10 is configured such that externalsystem 50 transmits data (e.g. data and power) to one or moreimplantable devices 200, and each implantable device 200 recovers (e.g.decodes, demodulates or otherwise recovers) the transmitted data withoutsynchronizing to the carrier and/or data symbol rate of the transmittedsignal from external system 50. In some embodiments, the transmittedsignal comprises a power signal, and a clock and/or data is recoveredwithout synchronizing to the power signal. In some embodiments, thetransmitted signal comprises a clock and/or data signal, and a clockand/or data is recovered without synchronizing to the transmitted clockand/or data signal. In some embodiments, the recovered signal comprisesa clock and/or data and a clock and/or data is recovered from thetransmission signal without synchronizing to the recovered clock and/ordata. Avoiding synchronization reduces power consumption of eachimplantable device 200, such as by obviating the need for (and avoidingthe power consumed by) a frequency locked loop (FLL); phase locked loop(PLL); high frequency clock; and/or crystal oscillator needed to performthe synchronization. Avoiding these components can also be correlated toreduced package size of each implantable device 200 (e.g. avoidance of arelatively large sized crystal oscillator). Asynchronous data transferbetween external system 50 and each implantable device 200 is alsoadvantageous as it relates to: increased communication data rate; powertransfer efficiency; operation with more than one implantable device200; and combinations of one or more of these. In some embodiments, oneor more components of apparatus 10 are of similar construction andarrangement as similar components described in U.S. patent applicationSer. No. 13/591,188, titled “Method of Making and Using an Apparatus fora Locomotive Micro-Implant using Active Electromagnetic Propulsion”,filed Aug. 21, 2012, the content of which is incorporated herein byreference in its entirety for all purposes. In some embodiments,external system 50 and implantable system 20 provide asynchronous datatransfer or are otherwise configured as described in U.S. patentapplication Ser. No. 13/734,772, titled “Method and Apparatus forEfficient Communication with Implantable Devices”, filed Jan. 4, 2013,the content of which is incorporated herein by reference in its entiretyfor all purposes.

Apparatus 10 can be configured to treat pain, such as back and/or legpain treated by stimulating dorsal root ganglia, and/or other nerves orlocations of the spinal cord or other nervous system locations. In someembodiments, apparatus 10 is configured to treat a type of pain selectedfrom the group consisting of: back pain; joint pain; neuropathic pain;tennis elbow; muscle pain; shoulder pain; chronic, intractable pain ofthe back and/or lower limbs including unilateral or bilateral pain;neuropathic groin pain; perineal pain; phantom limb pain; complexregional pain syndrome; failed back surgery syndrome; cluster headaches;migraines; inflammatory pain; arthritis; abdominal pain; pelvic pain;and combinations of one or more of these. In some embodiments, apparatus10 is configured to treat a patient disease or disorder selected fromthe group consisting of: chronic pain; acute pain; migraine; clusterheadaches; urge incontinence; pelvic dysfunction such as overactivebladder; fecal incontinence; bowel disorders; tremor; obsessivecompulsive disorder; depression; epilepsy; inflammation; tinnitus; highblood pressure; heart failure; carpal tunnel syndrome; sleep apnea;obstructive sleep apnea; dystonia; interstitial cystitis; gastroparesis;obesity; mobility issues; arrhythmia; rheumatoid arthritis; dementia;Alzheimer's disease; eating disorder; addiction; traumatic brain injury;chronic angina; congestive heart failure; muscle atrophy; inadequatebone growth; post-laminectomy pain; liver disease; Crohn's disease;irritable bowel syndrome; erectile dysfunction; kidney disease; andcombinations of one or more of these.

Apparatus 10 can be configured to treat heart disease, such as heartfailure of a patient. In these embodiments, stimulation of the spinalcord can be performed. In canine and porcine animals with failinghearts, spinal cord stimulation has been shown to reverse leftventricular dilation and improve cardiac function, while suppressing theprevalence of cardiac arrhythmias. In canines, coronary artery occlusionhas been associated with increased intracardiac nerve firing, andstimulation at spinal segment T1 has been shown to suppress that nervefiring. Stimulation via apparatus 10 at one or more spinal cordlocations can be used to suppress undesired cardiac nerve firing inhumans and other mammalian patients. In some embodiments, stimulationvia apparatus 10 at multiple spinal cord locations is used to enhance acardiac treatment. For example, one or more stimulation elements 260 oflead 265 can be implanted at one or more spinal cord locations. In someembodiments, stimulation elements 260 comprise two or more stimulationelements (e.g. electrodes) that span multiple vertebra of the spinalcolumn (e.g. multiple stimulation elements that span at least T8 to T9and/or T-9 to T-10). Lead 265 can receive stimulation energy for a firsttime period from a connected implantable device 200, and subsequentlyfor a second time period from a connected implantable device 800. One ormore stimulation signals can be delivered to spinal cord tissue, such asto treat heart failure or other cardiac disease or disorder. In someembodiments, one or more stimulation elements 260 are configured todeliver energy (e.g. electrical energy) to tissue to treat heartfailure, such as tissue selected from the group consisting of: spinalcanal; nerves in the spinal canal; nerves in the epidural space;peripheral nerves; posterior spinal nerve root; dorsal root; dorsal rootganglion; pre-ganglionic tissue on posterior spinal nerve root;post-ganglionic tissue on posterior nerve root; dorsal ramus; grey ramuscommunicans; white ramus communicans; ventral ramus; and combinations ofone or more of these. In some embodiments, one or more functionalelements of apparatus 10 (e.g. one or more stimulation elements 260 ofimplantable system 20) are used to record a patient parameter, such as apatient heart or spine parameter, and the information recorded is usedto adjust the delivered stimulation signals. The at least one heartparameter can comprise a parameter selected from the group consistingof: EKG; blood oxygen; blood pressure; heart rate; ejection fraction;wedge pressure; cardiac output; and combinations of one or more ofthese.

Apparatus 10 can be configured to pace and/or defibrillate the heart ofa patient. One or more stimulation elements 260 can be positionedproximate cardiac tissue and deliver a stimulation signal as describedherein (e.g. based on power and/or data received by implantable system20 from external system 50 or via an internal battery, such as energystorage assembly 870 of implantable device 800). The stimulation signalcan be used to pace, defibrillate and/or otherwise stimulate the heart.Alternatively or additionally, apparatus 10 can be configured to recordcardiac activity (e.g. by recording EKG, blood oxygen, blood pressure,heart rate, ejection fraction, wedge pressure, cardiac output, lungimpedance and/or other properties or functions of the cardiovascularsystem), such as to determine an onset of cardiac activity dysfunctionor other undesired cardiac state. In some embodiments, apparatus 10 isconfigured to both record cardiac or other information and deliver astimulation signal to cardiac tissue (e.g. stimulation varied orotherwise based on the recorded information). For example, apparatus 10can be configured such that external system 50 transmits power and/ordata to implantable system 20 while lead 265 is attached to animplantable device 200, and transmits data (only) to implantable system20 while lead 265 is attached to implantable device 800. Implantablesystem 20 monitors cardiac activity, and upon detection of an undesiredcardiovascular state, implantable system 20 delivers a pacing and/ordefibrillation signal to the tissue that is adjacent to one or morestimulation elements 260 configured to deliver a cardiac stimulationsignal.

External device 500 can comprise a wrist band, a wrist watch or an armband configuration such as when the implantable device 200 is positionedin subcutaneous tissue proximate the patient's wrist or upper arm. Theexternal device 500 can comprise a leg, knee or ankle bandconfiguration, such as when one or more implantable devices 200 arepositioned in subcutaneous tissue proximate the patient's thigh, kneeand/or ankle. In some embodiments, external device 500 comprises a bandor other attachment device for positioning about the thorax, neck, groinand/or head of the patient. Power and/or data can be sent to theimplantable device 200 from the external device 500, and data (e.g.blood glucose data) can be sent to external device 500 (or anothercomponent of external system 50) by implantable device 200, such asusing a communication configuration known to those of skill in the art.Various closed loop sensing and stimulation delivery combinations andconfigurations should be considered within the spirit and scope of thepresent inventive concepts, including but not limited to: sensing ablood parameter such as white blood cell count and adjusting energydelivery; sensing a hormone level and adjusting energy delivery; sensingblood pressure and adjusting energy delivery; sensing neural activityand adjusting energy delivery, such as for treating epilepsy; andcombinations of one or more of these.

External system 50 can be configured to transmit power and/or data (e.g.implantable device 200 configuration data) to one or more implantabledevices 200 of implantable system 20. External system 50 can beconfigured to transmit data (e.g. implantable device 800 configurationdata) to one or more implantable devices 800 of implantable system 20.Configuration data provided by external system 50 (e.g. via one or moreantennas 540 a of programmer 550 and/or one antennas 540 b of one ormore external devices 500, as described herein) can include when toinitiate stimulation delivery (e.g. energy delivery), when to stopstimulation delivery, and/or data related to the value or change to avalue of one or more stimulation settings as described herein. Theconfiguration data can include a sensing parameter, such as a sensingparameter selected from the group consisting of: initiation of sensorrecording; cessation of sensor recording; frequency of sensor recording;resolution of sensor recording; thresholds of sensor recording; samplingfrequency of sensor recording; dynamic range of sensor recording;initiation of calibration of sensor recording; and combinations of oneor more of these.

External system 50 can comprise one or more external devices 500 and/orone or more programmers 550. Programmer 550 can comprise one or moreantennas 540 a. Each external device 500 can comprise one or moreantennas 540 b. The one or more antennas 540 a and/or 540 b (generallyantenna 540) can transmit power and/or data to one or more antennas 240of each implantable device 200 and/or one or more antennas 840 of eachimplantable device 800, such as when a single implantable device 200and/or a single implantable device 800 comprises one or more antennas240 and/or 840 respectively, or when multiple implantable devices 200and/or 800 (singly or collectively implantable device 200/800) eachcomprise one or more antennas 240 and/or 840 (singly or collectivelyantenna 240/840), respectively. In some embodiments, one or moreantennas 540 define a radiation footprint (e.g. a footprint defining avolume, such as a volume of tissue, in which electromagnetictransmissions radiated by antennas 540 can be properly received byantennas 240/840), such as is described in applicant's co-pendingInternational PCT Patent Application Serial Number PCT/US2016/016888,titled “Medical Apparatus including an Implantable System and anExternal System”, filed Feb. 5, 2016; the content of which isincorporated herein by reference in its entirety for all purposes.

External system 50 transmits power and/or data with a transmissionsignal comprising at least one wavelength, λ. External system 50 and/orimplantable system 20 can be configured such that the distance betweenan external antenna 540 transmitting the power and/or data and one ormore implantable antennas 240/840 receiving the power and/or datatransmission signal is equal to between 0.1λ and 10.0λ, such as between0.2λ and 2.0λ. In some embodiments, one or more transmission signals aredelivered at a frequency range between 10 MHz and 10.6 GHz, such asbetween 0.1 GHz and 10.6 GHz, between 10 MHz and 3.0 GHz, between 40 MHzand 1.5 GHz, or between 0.902 GHz and 0.928 GHz, or in a frequency rangeproximate to 40.68 MHz, proximate to 866 MHz, or approximately between863 MHz and 870 MHz.

In addition to transmitting power and/or data to implantable system 20,external system 50 can be further configured to provide information(e.g. patient information and/or apparatus 10 performance information)to one or more other devices of apparatus 10, such as tool 60 shown inFIG. 1 and described in detail herebelow.

One or more external devices 500 (singly or collectively external device500) can be configured to transmit power and/or data (e.g. implantablesystem 20 configuration data) to one or more implantable devices200/800. In some embodiments, one or more external devices 500 areconfigured to transmit both power and data (e.g. simultaneously and/orsequentially) to one or more implantable devices 200. In someembodiments, one or more external devices 500 are further configured toreceive data from one or more implantable devices 200/800 (e.g. via datatransmitted by one or more antennas 240/840).

Each external device 500 can comprise housing 510, power supply 570, atransmitter 530, and/or one or more antennas 540 b, as described herein.

One or more housings 510 (singly or collectively housing 510) of eachexternal device 500 can comprise one or more rigid and/or flexiblematerials which surround various components of external device 500 suchas antenna 540 b, transmitter 530 and/or power supply 570. In someembodiments, a single external device 500 comprises multiple discrete(i.e. separate) housings 510, two or more of which can transfer data orother signals via a wired or wireless connection. In some embodiments,housing 510 comprises both a rigid material and a flexible material. Insome embodiments, housing 510 comprises a material selected from thegroup consisting of: plastic; injection-molded plastic; an elastomer;metal; and combinations of one or more of these. In some embodiments,housing 510 comprises a shielded portion (e.g. shielded to preventtransmission of electromagnetic waves), and an unshielded portion, suchas an unshielded portion surrounding antenna 540 b.

Housing 510 can comprise an adhesive element, not shown but such as anadhesive element configured to temporarily attach an external device 500to the patient's skin. Housing 510 can be constructed and arranged toengage (e.g. fit in the pocket of) a patient attachment device, such aspatient attachment device 70 described herebelow.

One or more antennas 540 a and/or 540 b (singly or collectively antenna540) can each comprise one, two, three or more external antennas.Antenna 540 can comprise one or more polarizable antennas, such as oneor more antennas with adjustable polarization. Antenna 540 can comprisean array of antennas, such as an array of antennas configured to:support beam shaping and/or focusing; allow adjustment of the amplitudeand/or phase of the transmission signal; increase the radiationfootprint; and combinations of one or more of these. An array ofantennas 540 can be configured to be selectively activated, such as toimprove coupling with one or more implanted antennas 240/840, such as toadjust for movement of the array of the antennas 540 relative to theimplanted antennas 240/840. Antenna 540 can comprise an array ofselectable conductors configured to adjust a radiation pattern and/or anelectromagnetic field of a resultant antenna. Antenna 540 can comprise asurface and shield material positioned on the surface, such as when theshield material is positioned on the side facing away from the patient'sskin. The shield material can comprise radio-absorptive shield materialand/or radio-reflective shield material. One or more antennas 540 can bepositioned in a housing (e.g. housing 510 or housing 551) that isotherwise void of other components (e.g. void of power supply 570 andtransmitter 530), such as when an antenna 540 is positioned within afirst housing 510 and communicates with components positioned in asecond housing 510.

In some embodiments, a spacer 511 is positioned between antenna 540 band the patient's skin, such as a spacer comprising a thickened portionof housing 510 or a discrete spacer 511 placed on a side of housing 510(as shown) or on a side of antenna 540 b. Spacer 511 can comprise one ormore materials that match the impedance of antenna 540 b to theimpedance of the patient's tissue. Spacer 511 can comprise a thicknessof between 0.1 cm to 3 cm, such as a thickness between 0.2 cm and 1.5cm. Spacer 511 can comprise materials which isolate heat (e.g. whenspacer 511 comprises a thermally insulating material). Alternatively, oradditionally, housing 510 can comprise a heat insulating and/ordissipating material. Spacer 511 can comprise a soft or otherwisecompressible material (e.g. foam) for patient comfort. Spacer 511 can beinflatable, such as to control the separation distance of an externalantenna 540 b from the patient's skin. An inflatable spacer 511 can becompartmentalized into several sections with independently controlledair pressure or volume to adjust the separation distance of an externalantenna 540 and the patient's skin and/or its angle (e.g. tilt) withrespect to the tissue surface.

In some embodiments, antenna 540 comprises a multi-feed point antenna,such as a multi-feed point antenna configured to: support beam shapingand/or focusing; allow adjustment of amplitude and/or phase of atransmission signal; increase the radiation footprint; or combinationsof one or more of these.

In some embodiments, antenna 540 comprises one or more antennas selectedfrom the group consisting of: patch antenna; slot antenna; array ofantennas; a loop antenna (e.g. a concentric loop antenna); antennaloaded with reactive elements; dipole antenna; polarizable antenna;selectable conductors that form an antenna; and combinations of one ormore of these.

Antenna 540 can comprise a major axis between 1 cm and 10 cm, such as amajor axis between 2 cm and 5 cm. Antenna 540 can be further configuredto receive a signal, such as when an antenna 240/840 is configured totransmit data to an external device 500 and/or programmer 550. Antenna540 can be positioned on (e.g. fabricated onto) a substrate, such as aflexible printed circuit board or other printed circuit board (e.g. asingle or multiple layer printed circuit board comprising electricaltraces connecting components).

A single external antenna 540 can be configured to transmit power and/ordata to multiple implantable devices 200/800 (e.g. each containing oneor more antennas 240/840). In some embodiments, a single external device500, comprising one or more antennas 540 b, can be configured totransmit power and/or data to multiple implantable devices 200.

One or more antennas 540 can comprise a multi-turn spiral loop antenna,such as a multi-turn spiral loop antenna configured to desensitizecoupling sensitivity and/or boost input voltage. In some embodiments,one or more antennas 540 comprise multiple concentric loops with varieddimensions, such as concentric loops configured to desensitize couplingsensitivity. In these embodiments, the multiple concentric loops can be:connected in parallel and driven from the same feed point; driven fromthe same feed point and connected using one or more of a capacitor,inductor, varactor, and combinations of one or more of these; and/ordriven from multiple feed points.

In some embodiments, one or more external devices 500 and/or programmer550 comprise a first antenna 540 and a second antenna 540. In theseembodiments, the first antenna 540 can be similar or dissimilar to thesecond antenna 540. In some embodiments, a first antenna 540 and adissimilar second antenna 540 are positioned within a single externaldevice 500 (e.g. within housing 510) and/or a single programmer 550(e.g. within housing 551). In other embodiments, a first antenna 540 ispositioned in a first external device 500, and a dissimilar secondantenna 540 is positioned in a second external device 500. Thesimilarity or dissimilarity of the antennas can be configured to enhanceone or more design and/or performance parameters selected from the groupconsisting of: implantable device 200/800 operation depth; polarization;power efficiency; a radiation footprint; directional gain; beam shapingand/or focusing; sensitivity to implantable device 200/800 placement;patient comfort; patient usability; data transfer; and combinations ofone or more of these. In some embodiments, the first antenna 540 can beoptimized for a different design parameter than the second antenna 540,and each antenna 540 can be activated independently or simultaneously torealize both benefits. In some embodiments, the first antenna 540 can besimilar to the second antenna 540 and placed in an array to increase theradiation footprint or placed in different external locations to operatewith multiple implantable devices 200/800 implanted at different sites.

In some embodiments, a first external antenna 540 and a second externalantenna 540 transmit power and/or data to a single implantable antenna240 or 840. In some embodiments, a first antenna 540 and a secondantenna 540 can transmit power and/or data to two or more antennas240/840, the transmissions occurring simultaneously or sequentially. Insequential power and/or data transfers, a first external device 500comprising a first one or more antennas 540 b can be replaced (e.g.swapped) with a second external device 500 comprising a second one ormore antennas 540 b. Alternatively or additionally, sequential powerand/or data transfer can be initiated by one or more of the followingconditions: when the first external antenna 540 moves (e.g. movesrelative to the implanted antenna 240/840); when a second externaldevice 500 comprising a second antenna 540 b is turned on or otherwiseactivated; when a second antenna 540 provides improved power and/or datatransfer to the antenna 240/840 than is provided by a first antenna 540;and/or when power received from a first antenna 540 decreases (e.g.decreases below a threshold). In some embodiments, an antenna 240receives power from a first antenna 540 and a second antenna 540, butonly receives data from the first antenna 540. In some embodiments, afirst antenna (e.g. an antenna 240, an antenna 840, or an antenna 540)is driven with a different carrier signal than a second antenna (e.g. anantenna 240, an antenna 840, or an antenna 540). The two carrier signalscan comprise differences in amplitudes and/or relative phases ascompared to each other. Each carrier signal can include a datatransmission signal (e.g. data to be transmitted to an implantabledevice 200/800 from an external device 500 or to an external device 500from an implantable device 200/800).

As described herein, one or more programmers 550 and/or external devices500 can be configured to transmit data (e.g. configuration data) to oneor more implantable devices 200/800. In programmer 550, antenna 540 atransmits the data-based transmission signal produced by transmitter553. In external device 500, antenna 540 b transmits the data-basedtransmission signal produced by transmitter 530. In some embodiments, atransmitter 553 and/or a transmitter 530 (singly or collectivelytransmitter 553/530) is configured to perform data modulation comprisingamplitude shift keying with pulse width modulation. In theseembodiments, the transmitter can be configured to perform multi-levelamplitude shift keying. The amplitude shift-keying can be configured toprovide adjustable-depth modulation between 0-100% depth, such asbetween 5-75% depth, or such as between 10-50% depth. In someembodiments, programmer 550 and/or one or more external devices 500transmit data to one or more implantable devices 200/800 using timedivision multiple access (TDMA). In some embodiments, one or implantabledevices 200/800 are independently addressable through uniqueidentification (ID) codes. Alternatively or additionally, transmitters553/530 can be configured to transmit one or more data signals with abandwidth between 1 kHz and 100 MHz, between 0.1 MHz and 100 MHz, orbetween 1 MHz and 26 MHz.

One or more transmitters 553/530 can each comprise one or more externaltransmitters that drive one or more antennas 540. In some embodiments,transmitter 553/530 comprises a transmitter that operates in a frequencyrange between 10 MHz and 10.6 GHz, such as a transmitter that operatesin a frequency range between 0.1 GHz and 10.6 GHz, between 10 MHz and3.0 GHz, between 40 MHz and 1.5 GHz, or between 0.902 GHz and 0.928 GHz,or in a frequency range proximate to 40.68 MHz, proximate to 866 MHz, orapproximately between 863 MHz and 870 MHz. Transmitter 553/530 cancomprise a transmitter that produces a transmission signal with a powerlevel between 0.1 W and 4.0 W, such as a transmission signal with apower level between 0.1 W and 2.0 W or between 0.2 W and 1.0 W.

As described herein, one or more external devices 500 can be configuredto transmit power to one or more implantable devices 200, such as via apower transmission produced by transmitter 530 and sent to one or moreantennas 540 b. One or more transmitters 530 can deliver power to one ormore implantable devices 200 simultaneously or sequentially. In someembodiments, one or more transmitters 530 are configured to adjust thelevel of power transmitted to one or more implantable devices 200/800,such as by adjusting one or more duty cycling parameters. In theseembodiments, power transmitted can be adjusted to: set a power transferbased on a stimulation level produced by implantable system 20; preventoversaturation; to reduce interference with implantable system 20 datatransmissions (e.g. when one or more implantable devices 200/800 arefurther configured to transmit data to external system 50); set a powertransfer based on charge information and/or discharge informationrelated to an implantable device 200/800 (e.g. charge rate and/ordischarge rate of an implantable energy storage assembly 270 and/or870); and combinations of one or more of these. In some embodiments,implantable system 20 comprises a first receiver 230 (e.g. of a firstimplantable device 200) and a second receiver 230 (e.g. of a secondimplantable device 200). One or more transmitters 530 can be configuredto transmit a first power transmission to the first receiver 230, and asecond power transmission to the second receiver 230. The first powertransmission and the second power transmission can be adjusted orotherwise be different, such as to prevent oversaturation.

In some embodiments, transmitter 553/530 (and/or another component ofexternal system 50) is further configured as a receiver, such as toreceive data from implantable system 20. For example, a transmitter553/530 can be configured to receive data via one or more antennas240/840 of one or more implantable devices 200/800. Data received caninclude patient information (e.g. patient physiologic information,patient environment information or other patient information) and/orinformation related to an implantable system 20 parameter (e.g. animplantable device 200/800 stimulation parameter and/or otherconfiguration parameter as described herein).

In some embodiments, transmitter 553/530 comprises a first transmitterto transmit power and/or data to one implantable device 200 or 800, anda second transmitter to transmit data to a different device. In theseembodiments, a second transmitter of transmitter 553/530 can beconfigured to transmit data to tool 60 or another device such as:external device 500 (e.g. when the transmission emanates fromtransmitter 553 of programmer 550); programmer 550 (e.g. when thetransmission emanates from transmitter 530 of external device 500); acell phone; a computer; a tablet; a computer network such as theinternet or a LAN; and combinations of one or more of these. In someembodiments, the second transmitter of transmitter 553/530 comprises awireless transmitter; a Bluetooth transmitter; a cellular transmitter;and combinations of one or more of these. In some embodiments, afunctional element 599 (e.g. functional element 599 a of programmer 550and/or functional element 599 b of external device 500) comprises atransmitter such as a Bluetooth transmitter.

Each power supply 557 and/or 570 (singly or collectively power supply557/570) can be operably attached to a transmitter 553/530, and one ormore other electrical components of programmer 550 or external device500, respectively. Power supply 557/570 can comprise a power supplyingand/or energy storage element selected from the group consisting of:battery; replaceable battery (e.g. via a battery door of housing 551 or510, respectively); rechargeable battery; AC power converter; capacitor;and combinations of one or more of these. In some embodiments, powersupply 557/570 comprises two or more batteries, such as two or morerechargeable batteries, such as to allow the first battery to bereplaced (e.g. serially replaced) by the second battery. In someembodiments, power supply 557/570 is configured to provide a voltage ofat least 3V. In some embodiments, power supply 557/570 is configured toprovide a capacity between 1 Watt-hour and 75 Watt-hours, such as abattery or capacitor with a capacity of approximately 5 Watt-hours. Insome embodiments, power supply 557/570 comprises an AC power source.

Each programmer 550 (singly or collectively programmer 550) comprises aprogramming device configured to control one or more components ofapparatus 10, such as implantable device 200/800. Programmer 550 cancomprise a user interface 555. Programmer 550 can send and/or receivecommands to and/or from one or more external devices 500, such as via awireless or wired connection (wired connection not shown but such as oneor more insulated conductive wires). In some embodiments, one or moreexternal devices 500 comprise programmer 550, such as when userinterface 555 is integrated into housing 510 of external device 500. Insome embodiments, apparatus 10 comprises multiple programmers 550.

Programmer 550 can be configured to adjust one or more parameters ofapparatus 10, such as a stimulation parameter (e.g. a stimulationwaveform parameter as described herein); a sensing parameter; a therapyparameter; a data recording parameter (e.g. a patient data recordingparameter and/or an implantable device 200/800 data recordingparameter); power transfer; data rate; activity of one or more externaltransmitters 553/530; activity of one or more external antennas 540; astimulation element 260 parameter; a functional element 599 parameter;and combinations of one or more of these. Programmer 550 can be furtherconfigured to provide information, such as patient physiologicinformation recorded by one or more implantable devices 200/800, orapparatus 10 information, such as performance and/or configurationinformation (singly or collectively “status information”) of one or moreexternal devices 500 and/or implantable devices 200/800. In someembodiments, the programmer 550 uses information recorded by one or moreimplantable devices 200, implantable device 800, apparatus 10information, and/or information from external devices 500 to adaptconfiguration parameters of one or more components of apparatus 10.

In some embodiments, programmer 550 comprises a lookup table ofstimulation signal waveform patterns, such as to allow a clinician,patient and/or other operator of apparatus 10 to select a predeterminedstimulation pattern. In some embodiments, programmer 550 comprises a setof adjustable stimulation signal parameters configured to be varied toallow an operator to construct customized waveforms, such as to vary oneor more stimulation parameters described hereabove. In some embodiments,the programmer 550 is configured to allow an operator to create acustomized waveform by specifying an amplitude of one or more discretepulses or steps of a stimulation signal to be delivered by animplantable device 200/800.

In some embodiments, programmer 550 comprises a transmitter 553configured to transmit data to tool 60 or another device such as a cellphone; computer; tablet; computer network such as the internet or a LAN;and combinations of one or more of these. In these embodiments,transmitter 553 can comprise a wireless transmitter; a Bluetoothtransmitter; a cellular transmitter; and combinations of one or more ofthese. In some embodiments, programmer 550 comprises a receiverconfigured to receive data, or a transceiver configured to both transmitand receive data.

User interface 555 of programmer 550 can comprise one or more user inputcomponents and/or user output components, such as a component selectedfrom the group consisting of: keyboard; mouse; keypad; switch; membraneswitch; touchscreen; display; audio transducer such as a speaker orbuzzer; vibrational transducer; light such as an LED; and combinationsof one or more of these.

In some embodiments, one or more components of external system 50 and/orother external component of apparatus 10, comprises one or morefunctional elements 599, such as functional elements 599 a and/or 599 b(singly or collectively functional element 599), shown positioned inprogrammer 550 and in external device 500, respectively. In someembodiments, one or more components of implantable system 20 cancomprise one or more functional elements, such as functional element 299of implantable device 200 and functional element 899 of implantabledevice 800, each shown in FIG. 1 . Each functional element 299, 599and/or 899 (singly or collectively functional element 299/599/899) canbe configured as defined hereabove (e.g. a sensor, a transducer, and/orother functional element as described herein).

In some embodiments, a functional element 599 comprises one or moresensors configured to monitor performance of external device 500 and/orprogrammer 550 (e.g. to monitor the voltage of power supply 570, qualityof transmission of power and/or data to implantable system 20,temperature of a portion of an external device 500, and the like).

In some embodiments, the functional element 299/599/899 can comprise anelectrode for sensing electrical activity and/or delivering electricalenergy. In some embodiments, apparatus 10 is configured to causestochastic resonance, and the addition of white noise can enhance thesensitivity of nerves to be stimulated and/or boost weak signals to berecorded by the one or more stimulation elements 260 and/or one or morefunctional elements 299/599/899.

In some embodiments, one or more functional elements 299/599/899comprise a sensor, such as a sensor configured to record data related toa patient parameter (e.g. a patient physiologic parameter), an externalsystem 50 parameter and/or an implantable system 20 parameter. In someembodiments, operation of one or more implantable devices 200/800 (e.g.stimulation energy delivered by one or more implantable devices 200/800)is configured to be delivered based on the data recorded by one or moresensor-based functional elements 299/599/899, such as in a closed-loopenergy delivery mode.

Functional element 299/599/899 can comprise one or more sensorsconfigured to record data regarding a patient parameter selected fromthe group consisting of: blood glucose; blood pressure; EKG; heart rate;cardiac output; oxygen level; pH level; pH of blood; pH of a bodilyfluid; tissue temperature; inflammation level; bacteria level; type ofbacteria present; gas level; blood gas level; neural activity; neuralspikes; neural spike shape; action potential; local field potential(LFP); EEG; muscular activity; electrical activity produced by skeletalmuscles (e.g. as measured using electromyography, EMG); gastric volume;peristalsis rate; impedance; tissue impedance; electrode-tissueinterface impedance; physical activity level; pain level; body position;body motion; organ motion; respiration rate; respiration level;perspiration rate; sleep level; sleep cycle; digestion state; digestionlevel; urine production; urine flow; bowel movement; tremor; ionconcentration; chemical concentration; hormone level; viscosity of abodily fluid; patient hydration level; and combinations of one or moreof these.

Functional element 299/599/899 can comprise one or more sensorsconfigured to record data representing a parameter of external system50, implantable system 20, and/or any component of apparatus 10.Functional element 299/599/899 can comprise one or more sensors selectedfrom the group consisting of: an energy sensor; a voltage sensor; acurrent sensor; a temperature sensor (e.g. a temperature of one or morecomponents of external device 500, programmer 550, and/or implantabledevice 200/800); an antenna matching and/or mismatching assessmentsensor; power transfer sensor; link gain sensor; power use sensor;energy level sensor; energy charge rate sensor; energy discharge ratesensor; impedance sensor; load impedance sensor; instantaneous powerusage sensor; average power usage sensor; bit error rate sensor; signalintegrity sensor; and combinations of one or more of these. Apparatus 10can be configured to analyze (e.g. via controller 250 and/or 850described herebelow) the data recorded by functional element 299/599/899to assess one or more of: power transfer; link gain; power use; energywithin power supply 557/570; performance of power supply 557/570;expected life of power supply 557/570; discharge rate of power supply557/570; ripple or other variations of power supply 557/570; matching ofantennas 240/840 and 540; communication error rate between implantabledevice 200/800 and external device 500; integrity of transmissionbetween implantable device 200/800 and external device 500; andcombinations of one or more of these.

In some embodiments, functional element 299 and/or functional element899 (singly or collectively 299/899) comprises a sensor configured toproduce a signal relating to the level of contamination in an undesiredlocation (e.g. within implantable device 200/800 and/or within theconnection between implantable device 200/800 and lead 265). Forexample, functional element 299/899 can comprise acontamination-detecting sensor selected from the group consisting of: pHsensor; optical sensor; chemical sensor; and combinations of one or moreof these. In these embodiments, apparatus 10 can be configured to enteran alarm state (e.g. produce an audible, tactile or visual alarm such asan alarm produced by external device 500, controller 550 and/orimplantable device 200/800) when a contamination level exceeds athreshold.

In some embodiments, one or more functional elements 599 are positionedon housing 551 and/or 510 (singly or collectively housing 551/510). Afunctional element 599 can comprise a body conduction sensor, such as abody conduction sensor configured to record and/or receive data via skinconduction. A functional element 299/599/899 can be configured to recorddata associated with stimulation delivered by one or more implantabledevices 200/800 (e.g. record data associated with stimulation energydelivered by one or more stimulation elements 260), such as to provideclosed loop or semi-closed loop stimulation. A functional element299/599/899 can be configured to record temperature, such as whenapparatus 10 is configured to deactivate or otherwise modify theperformance of programmer 550, external device 500 and/or implantabledevice 200/800 when the recorded temperature (e.g. patient temperature,programmer 550 temperature, external device 500 temperature, and/orimplantable device 200/800 temperature) exceeds a threshold.

In some embodiments, programmer 550, external device 500, and/orimplantable device 200/800 comprises a temperature sensor, such asfunctional elements 299/599/899. The temperature-based functionalelement 299/599/899 can be positioned proximate one or more portions ofprogrammer 550, external device 500, and/or implantable device 200/800.In these embodiments, the temperature data recorded by the functionalelement 299/599/899 is used to adjust one or more of: matching network;stimulation level (e.g. stimulation energy delivered by one or moreimplantable devices 200/800); power transmission level (e.g. level ofpower transmitted between one or more external devices 500 and one ormore implantable devices 200/800); and combinations of one or more ofthese. In some embodiments, the temperature sensor-based functionalelement 299/599/899 is a part of a safety mechanism that deactivatesprogrammer 550, external device 500, and/or implantable device 200/800if the recorded temperature exceeds a threshold. Alternatively oradditionally, a temperature sensor-based functional element 299/599/899can be configured to measure temperature of the patient, such as whenplaced on housing 551/510, housing 210 and/or housing 810 (singly orcollectively housing 210/810), such as to adjust energy deliveryperformed by implantable device 200/800 based on the recorded patienttemperature.

In some embodiments, implantable system 20 comprises multipleimplantable devices 200, and implantable system 20 comprises a“multi-point ready” system in which the operation (e.g. energy delivery,data recording and/or other function) of the multiple implantabledevices 200 is performed simultaneously, asynchronously, and/orsequentially. The implantable devices 200 can be part of a networkincluding one or more external devices 500 in which the treating of apatient and/or the recording of patient information relies on operationof the implantable devices 200 at one or more implantation sites in asynchronized, asynchronized, and/or otherwise coordinated way. Thesynchronization or otherwise coordination can be controlled by a singleor multiple external devices 500, which can further be synchronized to asingle clock. Each implantable device 200 of implantable system 20 canreceive a power signal and/or a data signal from one or more externaldevices 500. In some embodiments of the multi-point ready implantablesystem 20, each implantable device 200 comprises a unique ID, such thateach implantable device 200 can be individually addressed (e.g. receiveunique signals from external system 50). In some embodiments, externalsystem 50 transmits high-bandwidth signals to implantable system 20,such that time-domain multiple access communication can be performedwhile operating in near real time. In some embodiments, implantablesystem 20 is configured as a multi-point ready system such thatstimulation energy delivered by implantable system 20 is independent ofpower received by implantable system 20 from external system 50.

Two implantable devices 200, or two discrete components of a singleimplantable device 200 (e.g. two components comprising or positioned indifferent housings), can be attached to each other by a connectingfilament as defined hereabove. In some embodiments, a connectingfilament comprises a user-attachable (e.g. clinician-attachable)connector on at least one end. The filament connector is configured tooperably attach to a mating connector on a component (e.g. a housing210) of an implantable device 200.

Each implantable device 200 is configured to receive power and/or data(e.g. implantable system 20 configuration data) from one or moreexternal devices 500. In some embodiments, one or more implantabledevices 200 are configured to receive both power and data (e.g.simultaneously and/or sequentially) from one or more external devices500. In some embodiments, a single external device 500 sends powerand/or data to multiple implantable devices 200. Alternatively oradditionally, a single implantable device 200 can receive power and/ordata from multiple external devices 500. In some embodiments, a firstexternal device 500 is positioned on or near the patient's skin at alocation proximate an implanted first implantable device 200, and asecond external device 500 is positioned on or near the patient's skin(generally “on” the patient's skin) at a location proximate an implantedsecond implantable device 200. In these embodiments, the first externaldevice 500 transmits data and/or power to at least the first implantabledevice 200 and the second external device 500 transmits data and/orpower to at least the second implantable device 200.

In some embodiments, one or more implantable devices 200/800 are furtherconfigured to transmit data to programmer 550 and/or one or moreexternal devices 500, such as via one or more antennas 240/840transmitting a signal to one or more antennas 540. Data transmitted byan implantable device 200/800 can comprise patient information (e.g.patient physiologic information recorded by one or more stimulationelements 260 or functional elements 299/599/899 configured as aphysiologic sensor), or implantable device 200/800 information (e.g.data recorded by one or more sensors positioned in implantable device200/800, or other implantable device 200/800 configuration and/orperformance data).

Housing 210/810 of each implantable device 200/800, can comprise one ormore rigid and/or flexible materials. Housing 210 can surround variouscomponents of implantable device 200, such as antenna 240, energystorage assembly 270, controller 250 and/or receiver 230. Housing 810can surround various components of implantable device 800, such asantenna 840, energy storage assembly 870, controller 850 and/or receiver830. In some embodiments, one or more stimulation elements 260 arepositioned in, on and/or within housing 210/810. In some embodiments,housing 210/810 surrounds a substrate, such as a flexible and/orfoldable printed circuit board, such as multiple discrete or continuousprinted circuit boards positioned in different planes (e.g. a flexibleor foldable printed circuit board).

Housing 210/810 can comprise one or more shapes or combination ofshapes, such as one or more shapes selected from the group consistingof: disc; pill; cylinder; sphere; oblate spheroid; dish-like shape;bowl-like shape; cone; rectangular prism; trapezoidal prism; a portionof a toroid; and combinations of one or more of these.

Housing 210/810 can comprise a major axis and a minor axis, as definedhereabove. In some embodiments, housing 210/810 comprises a major axisless than or equal to 20 mm, such as a major axis less than or equal to15 mm, 12 mm or 10 mm. In some embodiments, housing 210/810 comprises aminor axis less than or equal to 8 mm, such as a minor axis less than orequal to 6 mm, or less than or equal to 5 mm Housing 210/810 cancomprise a wall thickness between 0.1 mm and 1.0 mm, such as a wallthickness between 0.2 mm and 0.5 mm, such as a wall thickness ofapproximately 0.3 mm Housing 210/810 can comprise a displacement volumeless than or equal to 2000 mm³, such as less than or equal to 600 mm³.

Housing 210/810 can comprise one or more portions that are transmissiveto radiofrequency (RF) signals. In some embodiments, housing 210/810comprises glass. In some embodiments, housing 210/810 comprises amaterial selected from the group consisting of: glass; ceramic;stainless steel; titanium; polyurethane; an organic compound; liquidcrystal polymer (LCP); gold; platinum; tungsten; epoxy; a thermoplastic;a thermoset plastic; and combinations of one or more of these. In someembodiments, one or more portions of housing 210/810 comprises one ormore coatings, such as one or more coatings configured to cause orprevent a physiologic reaction and/or a coating configured to block(e.g. shield) an electromagnetic transmission.

Housing 210/810 can comprise one or more passageways or otherfeedthroughs, such as for the passage of a lead, wire, optical fiber,fluid delivery tube, mechanical linkage and/or other conduit through awall of housing 210/810, such as is described in applicant's co-pendingInternational PCT Patent Application Serial Number PCT/US2016/016888,titled “Medical Apparatus including an Implantable System and anExternal System”, filed Feb. 5, 2016; the content of which isincorporated herein by reference in its entirety for all purposes. Insome embodiments, housing 210 comprises an array of feedthroughs. Insome embodiments, housing 210/810 is surrounded by a covering, such as aflexible and/or non-conductive covering, such as a covering made of anelastomer.

In some embodiments, one or more implantable devices 200/800 comprisesone or more anchor elements configured to secure one or more portions ofimplantable device 200/800 to tissue. The one or more anchor elementscan comprise one or more anchoring elements selected from the groupconsisting of: a sleeve such as a silicone sleeve; suture tab; sutureeyelet; bone anchor, wire loops; porous mesh; penetrable wing;penetrable tab; bone screw eyelet; tine; pincers; suture slits; andcombinations of one or more of these.

One or more antennas 240/840 can be configured to receive power and/ordata, and receiver 230 and/or receiver 830 (singly or collectivelyreceiver 230/830) can receive the power and/or data from the one or moreantennas 240/840, respectively. Each antenna 240/840 can comprise one ormore implantable antennas, such as one or more antennas positionedwithin housing 210/810, and/or one or more antennas electricallyattached to a connecting filament. In some embodiments, one or moreimplantable devices 200/800 comprise at least two antennas 240/840, orat least three antennas 240/840. Antenna 240/840 can be configured toreceive power and/or data from one or more external devices 500 and/orprogrammer 550, such that an attached receiver 230/830 receives thepower and/or data. In some embodiments, receiver 830 is not configuredto receive power, simply data. In some embodiments, implantable system20 comprises at least two implantable devices 200/800, each of whichcomprise one or more (e.g. two or three) antennas 240/840 which arepositioned within a housing 210/810 and/or electrically tethered to ahousing 210/810. In some embodiments, an implantable device 200/800comprises a first antenna 240/840 positioned in a first plane and asecond antenna 240/840 positioned in a second plane. The first plane andsecond plane can be relatively orthogonal planes, or planes orientedbetween 30° and 90° relative to each other, such as between 40° and 90°,approximately 30°, approximately 45° and/or approximately 60° relativeto each other. In some embodiments, an implantable device 200/800comprises a first antenna 240/840 positioned in a first plane, a secondantenna 240/840 positioned in a second plane, and a third antenna240/840 positioned in a third plane.

In some embodiments, implantable device 200/800 comprises one or moreantennas 240/840 positioned on a substrate, such as a printed circuitboard (PCB), a flexible printed circuit board and/or a foldablesubstrate (e.g. a substrate comprising rigid portions and hingedportions). In some embodiments, the substrate can be folded or otherwisepivoted to position the various antennas 240/840 on differently orientedplanes, such as multiple planes oriented between 5° and 90° relative toeach other, such as two antennas 240/840 positioned on two planesoriented between 30° and 90° or between 40° and 90° relative to eachother, or three antennas 240/840 positioned on three planes orientedbetween 5° and 60° relative to each other. Two or more antennas 240/840can be positioned on two or more different planes that are approximately45° relative to each other, or approximately 60° or approximately 90°relative to each other.

Implantable device 200/800 can comprise three antennas 240/840. In someembodiments, a first antenna 240/840 can comprise an electrical dipoleantenna, and the second and third antennas 240/840 can be positioned indifferent planes than the first antenna 240/840. In some embodiments,the three antennas 240/840 each comprise a loop antenna, such as wheneach loop antenna is positioned on a different plane. In someembodiments, a first antenna 240/840 comprises an electrical dipoleantenna, and a second antenna 240/840 and a third antenna 240/840 eachcomprise a loop antenna. In these embodiments, the second antenna240/840 and the third antenna 240/840 can be positioned relativelyorthogonal to each other (e.g. positioned on two relatively orthogonalplanes). In some embodiments, a first antenna 240/840 (e.g. anelectrical dipole antenna) is positioned outside of housing 210/810,while a second antenna 240/840 (e.g. a loop antenna) and a third antenna240/840 (e.g. a loop antenna) are each positioned on, in and/or withinhousing 210/810. In some embodiments, implantable device 200/800 cancomprise one or more antennas 240/840 in which any combination ofantenna types (as described herein) are used in combination.

One or more antennas 240/840 can comprise an antenna selected from thegroup consisting of: loop antenna; multiple-turn loop antenna; planarloop antenna; coil antenna; dipole antenna; electric dipole antenna;magnetic dipole antenna; patch antenna; loaded dipole antenna;concentric loop antenna; loop antenna with ferrite core; andcombinations of one or more of these. One or more antennas 240/840 cancomprise a loop antenna, such as an elongated loop antenna or amultiple-turn loop antenna.

One or more antennas 240/840 can comprise a multi-turn spiral loopantenna, such as a multi-turn spiral loop antenna configured todesensitize coupling sensitivity and/or boost input voltage. In someembodiments, one or more antennas 240/840 comprise multiple concentricloops with varied dimensions, such as concentric loops configured todesensitize coupling sensitivity. In these embodiments, the multipleconcentric loops can be: connected in parallel and driven from the samefeed point; driven from the same feed point and connected using one ormore of a capacitor, inductor, varactor, and combinations of one or moreof these; and/or driven from multiple feed points.

One or more antennas 240/840 can comprise a minor axis and a major axis.In some embodiments, one or more antennas 240/840 comprise a minor axisbetween 1 mm and 8 mm, such as between 2 mm and 5 mm. In someembodiments, one or more antennas 240/840 comprise a major axis between3 mm and 15 mm, such as between 4 mm and 8 mm. In some embodiments, oneor more antennas 240/840 comprise a major axis above 3 mm, such asbetween 3 mm and 15 mm, such as when the antenna 240/840 is positionedoutside of housing 210/810.

One or more antennas 240/840 can comprise a foldable and/or unfoldableantenna, such as is described in applicant's co-pending U.S. patentapplication Ser. No. 14/975,358, titled “Method and Apparatus forMinimally Invasive Implantable Modulators”, filed Dec. 18, 2015, thecontent of which is incorporated herein by reference in its entirety forall purposes.

One or more antennas 240/840 can be positioned inside of housing210/810. Alternatively or additionally, one or more antennas 240/840 canbe positioned outside of housing 210/810.

Implantable system 20, one or more implantable devices 200/800 and/orone or more antennas 240/840 can be configured to be positioned at adesired depth beneath the patient's skin, such as at a depth between 0.5cm and 7.0 cm, such as a depth of between 1.0 cm and 3.0 cm. In someembodiments, one or more antennas 840 are positioned at a deeper implantlocation than the depth at which one or more antennas 240 are implanted.

One or more energy storage assemblies 270 and/or 870 (singly orcollectively energy storage assembly 270/870) can comprise one or moreimplantable energy storage components, such as one or more batteries(e.g. rechargeable batteries) and/or capacitors (e.g. a supercapacitor).Energy storage assembly 270/870 can be configured to provide power toone or more of: one or more stimulation elements 260; controller250/850; receiver 230/830; and combinations of one or more of these. Insome embodiments, energy storage assembly 270/870 further provides powerto one or more antennas 240/840 and/or circuitry configured to transmitdata via antenna 240/840. In some embodiments, energy storage assembly270/870 includes digital control for charge/discharge rates, voltageoutputs, current outputs, and/or system power distribution and/ormanagement.

Energy storage assembly 270/870 can comprise one or more capacitors witha single or collective capacitance between 0.01 μF and 10F, such as acapacitance between 1 μF and 1.0 mF, or between 1 μF and 10 μF. Energystorage assembly 270/870 can comprise one or more capacitors with acapacitance between 1 mF and 10 F, such as when energy storage assembly270/870 comprises a super-capacitor and/or an ultra-capacitor. Suchlarge capacitance can be used to store sufficient charge to maintainoperation (e.g. maintain delivery of stimulation energy and/or deliveryof an agent) without the use (e.g. sufficient proximity) of anassociated power-providing external device 500. A capacitor or otherenergy storage element (e.g. a battery) can be chosen to providesufficient energy to maintain operation for at least 30 seconds, atleast 2 minutes, at least 5 minutes, at least 30 minutes, and/or up toseveral hours or more (e.g. during showering, swimming or other physicalactivity). In some embodiments, energy storage assembly 270/870 isconfigured to provide continuous and/or intermittent stimulation energyfor at least one charge-balanced pulse (e.g. for the duration of atleast one charge-balanced pulse). In some embodiments, a capacitor,battery or other energy storage element is configured to providestimulation energy without receiving externally supplied power forperiods of at least 1 hour, at least 1 day, at least 1 month or at least1 year (e.g. when implantable device 800 is configured to provide longterm stimulation without externally received power). Energy storageassembly 270/870 can comprise one or more capacitors with a breakdownvoltage above 1.0V, such as a breakdown voltage above 1.5V, 4.0V, 10V,or 15V. In some embodiments, energy storage assembly 270/870 cancomprise capacitors distributed outside of housing 210/810, such as whenone or more capacitors are distributed along lead 265. Energy storageassembly 270/870 can comprise one or more capacitors with lowself-leakage, such as to maintain stored energy for longer periods oftime.

In some embodiments, energy storage assembly 270/870, particularlyenergy storage assembly 270, comprises a temporary energy storagecomponent, such as a super-capacitor, configured to store a sufficientquantity of energy to provide uninterrupted stimulation, such as duringtime periods in which the link gain may be of poor quality or it may betemporarily unavailable (e.g. an external device 500 sending power to animplantable device 200 that is not in place, such as during a shower,swimming, and the like). An energy storage assembly 270 comprising anultra-capacitor, super-capacitor or flexible battery can be charged viathe wireless power transmission of the present inventive concepts, suchas to store a sufficient amount of energy for one or more stimulationelements 260 to deliver stimulation energy during subsequent (intendedor unintended) unavailability of one or more external devices 500 (e.g.an external device 500 is intentionally removed or unintentionally fallsoff or otherwise loses its position sufficiently proximate one or moreimplantable devices 200). An energy storage assembly 270 comprising oneor more high capacity energy storage components can be beneficial inapplications where therapy interruption provides a significant risk oris otherwise relatively unacceptable, such as for life supporttherapies, cardiac resynchronization therapies, and the like. The highcapacity energy storage components of energy storage assembly 270 can bepositioned in an assembly positioned within housing 210, on an inner orouter surface of housing 210, within a separate housing, and/or withinlead 265.

In some embodiments, implantable device 200 receives power regularlyfrom external system 20 (e.g. relatively continuously while implantabledevice 200 delivers stimulation energy), and energy storage assembly 270comprises a relatively small battery or capacitor, such as a battery orcapacitor that has an energy storage capacity of less than or equal to0.6 Joules, 7 Joules or 40 Joules. In these embodiments, implantabledevice 800 can receive no or minimal power regularly from externalsystem 20 (e.g. stimulation energy delivered by implantable device 800is provided by energy storage assembly 870), and energy storage assembly870 comprises a larger battery or capacitor than energy storage assembly270. For example, energy storage assembly 870 can be configured to storeat least 10 times the power stored in energy storage assembly 270, or atleast 100 times or 500 times the power stored in energy storage assembly270. In some embodiments, energy storage assembly 870 has a capacity ofat least 60 Joules, 700 Joules, or 4,000 Joules.

One or more controllers 250 and/or 850 (singly or collectivelycontroller 250/850) can be configured to control one or more stimulationelements 260, such as a stimulation element 260 comprising anenergy-delivering transducer (e.g. an electrode or other energy deliveryelement) and/or a sensor (e.g. a physiologic sensor and/or a sensorconfigured to monitor an implantable device 200/800 parameter). In someembodiments, controller 250/850 is configured to transmit a stimulationsignal (e.g. transmit stimulation energy configured in one or morestimulation waveforms) to one or more stimulation elements 260 (e.g. oneor more stimulation elements 260 comprising an electrode and/or otherenergy delivery element), independent of the power signal received byone or more antennas 240/840 (e.g. independent of power transmitted byexternal system 50), such as by using energy stored in energy storageassembly 270/870. In these embodiments, the power signal and/or the RFpath for the power signal can be adjusted to optimize power efficiency(e.g. by tuning matching network on transmitter 530 and/or receiver230/830; configuring antennas 540 and/or 240/840 in an array; tuningoperating frequency; duty cycling the power signal; adjusting antenna540 and/or 240/840 position; and the like), and a stimulation signal canbe precisely delivered (e.g. by using energy stored on energy storageassembly 270/870 and generating a stimulation signal locally on theimplantable device 200/800) to ensure clinical efficacy. Also, if thepower signal transmission (also referred to as “power link”) isperturbed unexpectedly, the stimulation signal can be configured so thatit is not significantly affected (e.g. unaffected). In someconfigurations, the stimulation signal being delivered by one or moreimplantable devices 200/800 can be insensitive to interference that maybe present. In these embodiments, a power transmission signal andstimulation signal can vary in one or more of: amplitude; changes inamplitude; average amplitude; frequency; changes in frequency; averagefrequency; phase; changes in phase; average phase; waveform shape; pulseshape; duty cycle; polarity; and combinations of one or more of these.

Controller 250/850 can receive commands from receiver 230/830, such asone or more commands related to one or more implantable device 200/800configuration parameters selected from the group consisting of:stimulation parameter; data rate of receiver; data rate of datatransmitted by implantable antenna 240/840; stimulation element 260configuration; state of controller 250/850; antenna 240/840 impedance;clock frequency; sensor configuration; electrode configuration; powermanagement parameter; energy storage assembly parameter; agent deliveryparameter; sensor configuration parameter; and combinations of one ormore of these.

In some embodiments, one or more stimulation elements 260 comprise astimulation element configured to deliver energy (e.g. one or moreelectrodes configured to deliver monopolar or bipolar electrical energy)to tissue, and controller 250/850 is configured to control the energydelivery, such as to control one or more stimulation parameters asdescribed herein. Each of these stimulation parameters can be heldrelatively constant, and/or varied, such as a variation performed in acontinuous or intermittent manner. In some embodiments, one or morestimulation parameters are varied in a random or pseudo-random(hereinafter “random”) manner, such as a variation performed byapparatus 10 using a probability distribution as described inapplicant's co-pending International PCT Patent Application SerialNumber PCT/US2017/017978, titled “Apparatus with Enhanced StimulationWaveforms”, filed Feb. 15, 2017, the content of which is incorporatedherein by reference in its entirety for all purposes. In someembodiments, stimulation (e.g. stimulation comprising high frequencyand/or low frequency signal components) is varied randomly to eliminateor at least reduce synchrony of neuronal firing with the stimulationsignal (e.g. to reduce paresthesia or other patient discomfort). In someembodiments, one or more stimulation elements 260 comprise a stimulationelement configured to stimulate a target (e.g. nerve tissue such asspinal nerve tissue and/or peripheral nerve tissue). The amount ofstimulation delivered to the target can be controlled by varying aparameter selected from the group consisting of: stimulation element 260size and/or configuration (e.g. electrode size and/or configuration);stimulation element 260 shape (e.g. electrode shape, magnetic fieldgenerating transducer shape or agent delivering element shape); shape ofa generated electric field; shape of a generated magnetic field;stimulation signal parameters; and combinations of one or more of these.

In some embodiments, one or more stimulation elements 260 comprise anelement configured to deliver electrical energy to tissue (e.g. one ormore electrodes configured to deliver monopolar or bipolar electricalenergy), and controller 250/850 is configured to control charge balance,such as to actively and/or passively control charge balance, asdescribed herebelow. Charge balance can be essential for patient safetyin electrical stimulation of nerves or other tissue. Imbalancedstimulation waveforms can cause electrode corrosion and/or dissolutionwhich can lead to deposition of toxic materials in tissue, implantrejection, and nerve damage. The stimulation waveform can be balancedsuch that net outflow charge approximately equals net inflow charge.With stimulation waveform amplitudes that can vary between 0.01 mA to 15mA (such as between 0.01 mA and 12 mA, or between 0.01 mA and 10 mA),depending on the treatment, the error in charge balance can be on theorder of 0.001% to 0.01%. Alternatively or additionally, controller250/850 can comprise AC coupling capacitors that are configured tobalance stimulation waveforms passively. The AC coupling capacitance canbe fairly large (e.g. greater than 10 μF), in order to pass thestimulation waveform with minimal filtering. In some embodiments,apparatus 10 can be configured to perform active charge balancing. Insome embodiments, an implantable device 200/800 can comprise a preciseresistor in series with a stimulation electrode-based stimulationelement 260. The precise resistor can be used to measure outflow andinflow currents, such as when controller 250/850 comprises an analog todigital converter (ADC). Controller 250/850 can integrate current overtime during a first phase in which stimulation energy is delivered, andduring a second phase in which a reverse current is applied (e.g. areverse current used to balance charge). Controller 250/850 can beconfigured to balance the total charge in the two phases, to ensure thatthe net DC current is approximately zero. The integration can beachieved using an analog integrator and/or a digital summer ofcontroller 250/850, with controller 250/850 keeping track of one or moreparameters of the pulses delivered (e.g. pulses delivered within a trainor a burst). Implantable device 200/800 can comprise a precise seriesresistance comprising an on-chip trimmed resistor or an off chipresistor. In some embodiments, implantable device 200/800 comprises abank of trimmed resistors that are used to control the net seriesresistance, such as to adjust resistance based on stimulation amplituderequirements (e.g. to take advantage of the full dynamic range of an ADCof controller 250/850). In some embodiments, controller 250/850comprises a shunt path with an RC-based low pass filter used for bothoutflow and inflow of current. RC elements of controller 250/850 can bechosen such that the shunt current is only a fraction of the stimulationcurrent. Since the same RC elements can be used for both outflow andinflow current, the precision required for the RC components can belower. An ADC can be used to sense the voltage on the capacitor at theend of a stimulation pulse. After the stimulation pulse, the capacitorcan be discharged and the polarity of the stimulation current can bereversed and set to any amplitude, until the capacitor is charged toapproximately the same voltage (according to the ADC precision) as itwas charged during the stimulation pulse. The ADC resolution can be highenough to ensure the residual error is less than what would cause anundesired charge accumulation. ADC resolution requirements can befurther reduced by reducing the net capacitance in a shunt RC circuit,to cause accelerated charging of the capacitor. The capacitor can bedischarged every time the voltage exceeds a certain predefinedthreshold, while controller 250/850 keeps track of the number of timesthe capacitor has been charged and reset. By resetting the capacitorthrough a low resistance path, the discharge time can be insignificantcompared to the charge time, reducing the error due to the dischargeperiod. Since the net charge equivalent to full scale voltage on the ADCcan be divided into multiple cycles, the required resolution of the ADCto achieve the same residual error can be divided by the number ofcycles.

In some embodiments, controller 250/850 is configured to produce astimulation signal comprising a waveform or a waveform pattern(hereinafter stimulation waveform), for one or more stimulation elements260 configured as a stimulation element (e.g. such that one or morestimulation elements 260 deliver stimulation energy comprising or atleast resembling that stimulation waveform). Controller 250/850 canproduce a stimulation signal comprising a waveform selected from thegroup consisting of: square wave; rectangle wave; sine wave; sawtooth;triangle wave (e.g. symmetric or asymmetric); trapezoidal; ramp;waveform with exponential increase; waveform with exponential decrease;pulse shape which minimizes power consumption; Gaussian pulse shape;pulse train; root-raised cosine; bipolar pulses; and combinations of oneor more of these. In some embodiments, controller 250/850 is configuredto produce a stimulation signal comprising a waveform including acombination of two or more waveforms selected from the group consistingof: square wave; rectangle wave; sine wave; triangle wave (symmetric orasymmetric); trapezoidal; ramp; waveform with exponential increase;waveform with exponential decrease; pulse shape which minimizes powerconsumption; Gaussian pulse shape; pulse train; root-raised cosine;bipolar pulses; and combinations of one or more of these. In someembodiments, controller 250/850 is configured to construct a customwaveform (e.g. an operator customized waveform), such as by adjustingamplitude at specified time steps (e.g. for one or more pulses). In someembodiments, controller 250/850 is configured to generate a waveformincluding one or more random parameters (e.g. random timing of pulses orrandom changes in frequency, rate of change or amplitude).

In some embodiments, controller 250/850 is configured to provide astimulation signal comprising waveforms and/or pulses repeated at afrequency (e.g. includes a frequency component) between 1.0 Hz and 50KHz, such as between 10 Hz and 500 Hz, between 40 Hz and 160 Hz and/orbetween 5 KHz and 15 KHz. In some embodiments, controller 250/850 isconfigured to produce a stimulation signal comprising a frequencybetween 1 Hz and 1000 Hz, such as a stimulation signal with a frequencybetween 10 Hz and 500 Hz. In some embodiments, controller 250/850 isconfigured to produce a stimulation signal comprising a duty cyclebetween 0.1% and 99%, such as a duty cycle between 1% and 10% or between1% and 25%. In some embodiments, controller 250/850 is configured toproduce a stimulation signal comprising a frequency modulatedstimulation waveform, such as a stimulation waveform comprising afrequency component (e.g. signal) between 1 kHz and 20 kHz. In someembodiments, controller 250/850 is configured to produce a stimulationsignal comprising a mix and/or modulation of low frequency and highfrequency signals, which can be of any of the waveform types, shapes andother configurations as described herein. In these embodiments, thestimulation signal can comprise low frequency signals between 1 Hz and1000 Hz, and high frequency signals between 600 Hz and 50 kHz, orbetween 1 kHz and 20 kHz. Alternatively or additionally, the stimulationsignal can comprise a train of high frequency signals and bursts of lowfrequency signals, and/or a train of low frequency signals and bursts ofhigh frequency signals. Alternatively or additionally, the stimulationsignal can comprise one or more high frequency signals modulated withone or more low frequency signals, such as one or more high frequencysignals frequency modulated (FM), amplitude modulated (AM), phasemodulated (PM) and/or pulse width modulated (PWM) with one or more lowfrequency signals. The stimulation signal can cycle among differentwaveforms shapes at specified time intervals. The stimulation signal cancomprise a pseudo random binary sequence (PRBS) non-return-to-zero orreturn-to-zero waveform, such as with a fixed and/or time-varying pulsewidth and/or frequency of the pulses.

Controller 250/850 can comprise a clamping circuit configured to allowfast charging and/or discharging of the energy storage assembly 270/870,stimulation element 260 drivers (e.g. electrode drivers) of controller250/850, and/or other components of implantable device 200/800. Theclamping circuit can improve pulse shape by offering additional controland/or configuration of rise and fall times in the shape of the waveform(e.g. to create rapid rise or fall times). In some embodiments, theclamping circuit can be configured to limit the rise and/or fall time tobe less than or equal to one-tenth (10%) of the pulse width of anapplied stimulation pulse (e.g. less than or equal to 1 μs rise and/orfall time for a 10 μs stimulation pulse).

In some embodiments, controller 250/850 comprises a matching networkconfigured to match the impedance of a first antenna 240/840 with theimpedance of the receiver 230/830. In these embodiments, controller250/850's matching network can be adjustable. Alternatively oradditionally, controller 250/850 can comprise an adjustable loadingimpedance to stabilize the load seen at an antenna 240/840 underdifferent operating conditions. In some embodiments, the adjustableloading impedance is controlled according to the charge rate of theenergy storage assembly 270/870.

Controller 250/850 and/or any other component of each implantable device200/800 can comprise an integrated circuit comprising one or morecomponents selected from the group consisting of: matching network;rectifier; DC-DC converter; regulator; bandgap reference; overvoltageprotection; overcurrent protection; active charge balance circuit;analog to digital converter (ADC); digital to analog converter (DAC);current driver; voltage driver; digital controller; clock generator;data receiver; data demodulator; data modulator; data transmitter;electrode drivers; sensing interface analog front end; power managementcircuit; energy storage interface; memory register; timing circuit; andcombinations of one or more of these.

One or more receivers 230/830 can each comprise one or more components,such as a demodulator, a rectifier and/or a power converter. In someembodiments, receiver 230/830 can comprise a DC-DC converter such as aboost converter. Receiver 230/830 can comprise a data receiver, such asa data receiver including an envelope detector and demodulator and/or anenvelope averaging circuit. In some embodiments, one more antennas240/840 separately connect to one or more receivers 230/830. In someembodiments, one or more antennas 240/840 connect to a single receiver230/830, such as via a series connection or a parallel connection.

One or more implantable devices 200/800 can be configured to transmit adata signal to external system 50. In some embodiments, receiver 230/830is configured to drive one or more antennas 240/840 to transmit data toexternal system 50 (e.g. to an antenna 540 a of programmer 550 orantenna 540 b of an external device 500). Alternatively or additionally,implantable device 200/800 can be configured to transmit a data signalby having receiver 230/830 adjust a load impedance to backscatterenergy, such as a backscattering of energy which can be detected byexternal system 50. In some embodiments, data transmission isaccomplished by receiver 230/830 manipulating a signal at a tissueinterface, such as to transmit a data signal using body conduction.

In some embodiments, receiver 230/830 comprises a matching network, suchas a matching network configured to detune to prevent oversaturation.For example, implantable system 20 can comprise two or more implantabledevices 200/800, and each of which can include a receiver 230/830comprising a matching network. A first implantable device 200/800'sreceiver 230/830's matching network can be configured to detune based onpower received by the second implantable device 200/800's receiver230/830.

A demodulator portion of receiver 230/830 can comprise circuitry thatasynchronously recovers signals modulated on the power signal providedby external system 50, and converts the modulated signals into digitalsignals. In some embodiments, the demodulator asynchronously recoversthe modulated signal by comparing a dynamically generated moving averagewith the envelope, outputting a high voltage when the envelope isgreater than the moving average and a low voltage when the envelope isless than the moving average. Data can then be extracted from thisresulting digital signal from the width and/or amplitude of the pulsesin the signal, according to the encoding method used by external system50. In some embodiments, the demodulator recovers a digital signal thatcan be used as timing information for an implantable device 200/800,similar to an on-chip clock. The recovered clock signal can also be usedto synchronize an on-chip clock generator of controller 250/850, such asthrough the use of a frequency and/or phase locked loop (FLL or PLL).

A rectifier portion of receiver 230/830 can comprise a power signalrectifier, such as to provide power to the energy storage assembly270/870 and/or controller 250/850. In some embodiments, the rectifiercomprises one or more self-driven synchronous rectifier (SDSR) stagesconnected in charge-pump configuration, to boost the voltage from aninput RF amplitude to the rectifier, to a higher voltage. The boostedvoltage can directly charge energy storage assembly 270/870, or befurther boosted by a DC-DC converter or boost converter. In someembodiments, the rectifier can comprise diode-capacitor ladder stagesinstead of, or in addition to, SDSR stages. On-chip diodes, such asSchottky diodes, or off-chip diodes can be used in one or more rectifierstages. For maximum efficiency, the rectification elements, such asdiodes, can be optimized to minimize forward conduction and/or reverseconduction losses by properly sizing the components and selectingappropriate number of stages based on the input RF voltage and loadcurrent.

A power converter portion of receiver 230/830 can comprise one or morevoltage conversion elements such as DC-DC converters that boost orotherwise change the voltage to a desired level. In some embodiments,voltage conversion is achieved with a buck-boost converter, a boostconverter, a switched capacitor, and/or charge pumps. One or more powerconverters can interface with energy storage assembly 270/870 and chargeup associated energy storage components to desired voltages. In someembodiments, a power converter receives control signals from controller250/850, such as to configure voltages, currents, charge/dischargerates, switching frequencies, and/or other operating parameters of thepower converter.

One or more implantable leads 265 (singly or collectively lead 265) canbe attached to one or more housings 210/810, such as at attachment port290 of implantable device 200 and/or attachment port 890 of implantabledevice 800. In some embodiments, various components of implantablesystem 20 are implanted in multiple clinical procedures, such as isdescribed herebelow in reference to FIG. 2 . For example, implantabledevice 200 can be implanted in a first clinical procedure in which lead265 is also implanted. In this first clinical procedure, lead 265 isoperably attached to implantable device 200 via attachment port 290.After the first clinical procedure, a “trial period” ensues in whichstimulation is provided in order to evaluate use of apparatus 10 toprovide therapy to the patient. During the trial period, stimulationsettings can be varied (e.g. variations of: stimulation element 260positions, configurations and/or combinations; stimulation frequencies;stimulation waveform shapes; and/or stimulation pulse width and/oramplitude). Today's clinical practice can include use of an externalstimulator during an evaluation period (e.g. similar to the “trialperiod” described herein) of a future implanted stimulator, such as anexternal stimulator that attaches to an implanted lead (e.g. a leadsimilar to lead 265), via a transcutaneous conduit. This externalstimulator approach during the evaluation period has numerousdisadvantages including risk of infection, which limits the duration ofthe evaluation period. Apparatus 10 of the present inventive conceptsincludes implantable stimulator 200, which is implanted in the patientfor use in the trial period, avoiding any transcutaneous conduits. Useof the implanted stimulator of the present inventive concepts during anevaluation phase can provide numerous advantages, including but notlimited to extended length of the trial period (e.g. due to thedecreased risk of infection of a fully implanted device), such as atrial period that lasts at least 1 week, at least 2 weeks, at least 1month, at least 2 months, and/or at least 3 months, greatly reduced riskof dislocating the implanted lead (e.g. a dislocation which could occurwith inadvertent tugging on a transcutaneous conduit), simplification ofpatient bathing (e.g. due to avoidance of transcutaneous conduit),and/or improved patient experience with apparatus (since long termdevice similarly does not include transcutaneous conduit). Use ofimplantable stimulator 200 versus an external simulator, during atrialing period as described herein, provides the patient with a similarexperience to that which will be encountered with implantable stimulator800 (e.g. since both are implanted). During the trialing period,implantable device 200 receives power and data from one or more externaldevices 500, as is described herein, avoiding the need for a largecapacity energy storage assembly 270 (e.g. reducing the volume ofimplantable device 200). After the trialing period, in a second clinicalprocedure, implantable device 200 is detached from lead 265, andimplantable device 800 is attached to lead 265 and implanted in thepatient (in any order). After implantation, implantable device 800provides long-term therapy to the patient for a therapy period (e.g. aperiod of at least 1 month, at least 6 months, at least 1 year or atleast 2 years). During the therapy period, implantable device 800 maynot receive any power from external system 50, such as when energystorage assembly 870 comprises a capacity sufficient to deliverstimulation for the entire therapy period. In alternative embodiments,energy storage assembly 870 is recharged periodically (e.g. notcontinuously), such as via a wireless recharge (e.g. via a RF or otherwireless transmitter, magnetic coupling, inductive coupling, capacitivecoupling and/or other wireless power transmission means).

Lead 265 comprises proximal portion 268, distal portion 269, and a shaft(e.g. a flexible shaft), shaft 261. Lead 265 comprises at least onestimulation element 260, such as two, three, four or more stimulationelements (three shown positioned on distal portion 269 in FIG. 1 ).Stimulation elements 260 can comprise electrodes or other energydelivering elements. Stimulation element 260 can comprise two or moreelectrodes configured to deliver energy in monopolar or bipolar energydelivery modes. In some embodiments, one or more stimulation elements260 and/or other component of implantable device 200/800 (e.g.functional elements 299 and/or 899) can be configured as a physiologicsensor (e.g. an electrode configured to record electrical activity oftissue or other physiologic sensor as described herein). One or morestimulation elements 260 can be configured to transmit signals throughtissue to one or more components of external system 50, such as throughbody conduction.

Stimulation elements 260 are operatively connected (e.g. electrically,optically, and/or acoustically connected) to contacts 262 via conduit263 (e.g. one or more wires, optical fibers, wave guides, and the like).Contacts 262, shown positioned on proximal portion 268 of lead 265, areconstructed and arranged to operatively connect to contacts 292 ofattachment port 290 (e.g. in a first clinical procedure), and contacts892 of attachment port 890 (e.g. in a subsequent, second clinicalprocedure). Contacts 292 and/or 892 (contacts 292/892 herein) areoperatively connected with various components of implantable device200/800 such that stimulation energy can be provided by implantabledevice 200/800 to stimulation elements 260 via attachment port 290/890and conduit 263.

In some embodiments, lead 265 comprises a removable stylet configured toaid in the implantation of lead 265, such as is described in applicant'sco-pending International PCT Patent Application Serial NumberPCT/US2016/016888, titled “Medical Apparatus including an ImplantableSystem and an External System”, filed Feb. 5, 2016; the content of whichis incorporated herein by reference in its entirety for all purposes. Insome embodiments, implantable system 20 comprises more than one lead265, each comprising one or more stimulation elements 260 and attachedto one or more attachment ports 290/890 of one or more implantabledevices 200/800.

In some embodiments, lead 265 comprises a diameter between 1 mm and 4mm, such as a diameter between 1 mm and 2 mm. In some embodiments, lead265 comprises a length between 3 cm and 60 cm, such as a length between6 cm and 30 cm. One or more leads 265 can include between 2-64stimulation elements 260, such as when a lead 265 comprises between 2and 64 electrodes, such as between 4 and 32 electrodes. In someembodiments, lead 265 comprises a paddle lead. In some embodiments,stimulation element 260 comprises one or more electrodes selected fromthe group consisting of: microelectrode; cuff electrode; array ofelectrodes; linear array of electrodes; circular array of electrodes;paddle-shaped array of electrodes; bifurcated electrodes; andcombinations of one or more of these.

In some embodiments, stimulation element 260 comprises one or moreelements positioned proximate and/or within one or more tissue typesand/or locations selected from the group consisting of: one or morenerves; one or more locations along, in and/or proximate to the spinalcord; peripheral nerves of the spinal cord including locations aroundthe back; the knee, the tibial nerve (and/or sensory fibers that lead tothe tibial nerve); the occipital nerve; the sphenopalatine ganglion; thesacral and/or pudendal nerve; brain tissue, such as the thalamus;baroreceptors in a blood vessel wall, such as in the carotid artery; oneor more muscles; the medial nerve; the hypoglossal nerve and/or one ormore muscles of the tongue; cardiac tissue; the anal sphincter; thedorsal root ganglion; motor nerves; muscle tissue; the spine; the vagusnerve; the renal nerve; an organ; the heart; the liver; the kidney; anartery; a vein; bone; and combinations of one or more of these, such asto stimulate and/or record data from the tissue and/or location in whichthe stimulation element 260 is positioned proximate to and/or within. Insome embodiments, apparatus 10, implantable device 200, implantabledevice 800, and/or stimulation element 260 are configured to stimulatespinal nerves, peripheral nerves and/or other tissue as described inapplicant's co-pending application International PCT Patent SerialNumber PCT/US2016/051177, titled “Apparatus for Peripheral or SpinalStimulation”, filed Sep. 9, 2016.

In some embodiments, stimulation element 260 or a component ofimplantable device 200/800 comprises one or more sensors configured torecord data representing a physiologic parameter of the patient.Stimulation element 260 can comprise one or more sensors selected fromthe group consisting of: electrode; sensor configured to recordelectrical activity of tissue; blood glucose sensor; gas sensor; bloodgas sensor; ion concentration sensor; oxygen sensor; pressure sensor;blood pressure sensor; heart rate sensor; cardiac output sensor;inflammation sensor; neural activity sensor; neural spike sensor;muscular activity sensor; EMG sensor, bladder volume sensor, bladderpressure sensor, gastric volume sensor; peristalsis rate sensor; pHsensor; strain gauge; accelerometer; gyroscope; GPS; respiration sensor;respiration rate sensor; flow sensor; viscosity sensor; temperaturesensor; magnetic sensor; optical sensor; MEMs sensor; chemical sensor;hormone sensor; impedance sensor; tissue impedance sensor;electrode-tissue interface impedance sensor; body position sensor; bodymotion sensor; organ motion sensor; physical activity level sensor;perspiration sensor; patient hydration sensor; breath monitoring sensor;sleep monitoring sensor; food intake monitoring sensor; digestionmonitoring sensor; urine movement sensor; bowel movement sensor; tremorsensor; pain level sensor; and combinations of one or more of these.

Apparatus 10 and stimulation element 260 can be configured to record apatient parameter (e.g. patient physiologic and/or patient environmentparameter) selected from the group consisting of: blood glucose; bloodpressure; EKG; heart rate; cardiac output; oxygen level; pH level; pH ofblood; pH of a bodily fluids; tissue temperature; inflammation level;bacteria level; type of bacteria present; gas level; blood gas level;neural activity; neural spikes; neural spike shape; action potential;local field potential (LFP); EEG; muscular activity; skeletal muscleactivity; bladder volume; bladder pressure; gastric volume; peristalsisrate; impedance; tissue impedance; electrode-tissue interface impedance;physical activity level; pain level; body position; body motion; organmotion; respiration rate; respiration level; perspiration rate; sleeplevel; sleep cycle; digestion state; digestion level; urine production;urine flow; bowel movement; tremor; ion concentration; chemicalconcentration; hormone level; viscosity of a bodily fluid; patienthydration level; and combinations of one or more of these.

In some embodiments, apparatus 10 comprises tool 60. Tool 60 cancomprise a data logging and/or analysis tool configured to receive datafrom external system 50 or implantable system 20, such as datacomprising: diagnostic information recorded by external system 50 and/orimplantable system 20; therapeutic information recorded by externalsystem 50 and/or implantable system 20; patient information (e.g.patient physiologic information) recorded by implantable system 20;patient environment information recorded by implantable system 20; andcombinations of one or more of these. Tool 60 can be configured toreceive data from wired or wireless (e.g. Bluetooth) means. Tool 60 cancomprise a tool selected from the group consisting of: a data loggingand/or storage tool; a data analysis tool; a network such as a LAN orthe Internet; a cell phone; and combinations of one or more of these.

In some embodiments, tool 60 comprises a battery charging assembly, suchas an assembly configured to recharge one or more power supplies 557and/or 570 comprising a rechargeable battery or capacitor.

In some embodiments, tool 60 comprises an implantation tool, such as anintroducer or other implantation tool constructed and arranged to aid inthe implantation of housing 210, housing 810, implantable antenna 240,implantable antenna 840, lead 265 and/or one or more stimulationelements 260.

In some embodiments, lead 265 comprises a paddle lead or otherstimulating lead and tool 60 comprises an introducer (e.g. a needle oran extended-width introducer) configured to deliver at least a distalportion of lead 265 into an epidural space of a patient. Tool 60 cancomprise an introducer comprising a Tuohy needle, such as a Tuohy needleof 12 gauge or smaller. Tool 60 can comprise a handle for manipulatinglead 265. Tool 60 can be configured to place lead 265 at an entry pointabove the lumbar spinal column (e.g. between L1 and L2 vertebrae). Tool60 can include extension tubing used to insert lead 265. Tool 60 canfurther comprise a tool configured to anchor lead 265, such as when tool60 comprises sutures, clips, other anchoring elements and/or an anchorsecuring tool (e.g. a needle or a stapling device), such as to securelead 265 in subcutaneous tissue. Lead 265 and/or tool 60 can compriseextension tubing used to place lead 265, such as extension tubing thatremains in place after removal of an introducer of tool 60. Tool 60 canbe configured to place lead 265 against the dura of the spinal cord ofthe patient.

In some embodiments, tool 60 and/or lead 265 are constructed andarranged to implant lead 265 to stimulate one or more multifidus (MF)muscle fascicles, such as at least three sets of multifidus musclefascicles. Lead 265 can be secured to a vertebra (e.g. on the transverseprocess, lamina or vertebral body). Lead 265 can be placed via tool 60such that one or more stimulation elements 260 (e.g. electrodes) arepositioned within the multifidus muscle structures. One or morestimulation elements 260 can be positioned to deliver electrical energyand/or to otherwise stimulate tissue selected from the group consistingof: muscle motor point(s) or the deep fibers of lumbar multifidus;quadratus lumborum; the erector spinae; psoas major; transverseabdominis; connective tissue such as the annulus or facet capsule;ligaments coupling bony structures of the spine; and combinations of oneor more of these. Stimulation elements 260 can be positioned to:depolarize, hyperpolarize and/or block innervated sections of the musclethat will then propagate an activating and/or inhibiting stimulus alongthe nerve fibers recruiting muscle tissue remote from the site ofstimulation and/or modulate nerve activity (including inhibiting nerveconduction, improving nerve conduction and/or improving muscleactivity). In some embodiments, stimulation elements 260 are positionedto cause transvascular stimulation (e.g. transvascular stimulation fromarteries and/or veins in a leg or arm). In some embodiments, stimulationelements 260 are positioned to stimulate nerve tissue selected from thegroup consisting of: dorsal ramus nerve; medial branch of dorsal ramusnerve; nervous tissue associated with multifidus muscle; andcombinations of one or more of these. In some embodiments, stimulationelements 260 are configured to deliver stimulation energy to contractthe multifidus muscle. In some embodiments, stimulation elements 260 areconfigured to stimulate tissue by providing episodic electricalstimulation. In some embodiments, apparatus 10 comprises a tool 60configured to diagnose a defect in spinal muscle or the motor controlsystem. In some embodiments, apparatus 10 comprises a tool 60 configuredto test function of the multifidus muscle, such as when tool 60comprises an MRI; ultrasound imager; electromyogram; tissue biopsydevice; and/or a device configured to test displacement as a function ofload for a spine.

In some embodiments, two or more external system 50 components areconnected by a connecting filament, such as is described hereabove.Alternatively or additionally, two or more implantable system 20components are connected by a conduit, such as a connecting filament asdescribed herein. Alternatively or additionally, two more externalsystem 50 components and/or two or more implantable system 20 componentstransmit information and/or power via a wireless transmitter (e.g. an RFtransmitter), magnetic coupling, inductive coupling, capacitive couplingand/or other wireless transmission means.

Apparatus 10 can include one or more devices, such as patient attachmentdevice 70 shown in FIG. 1 , that is used to attach one or more portionsof external system 50 to a location on or proximate the patient. In someembodiments, patient attachment device 70 is constructed and arranged asdescribed in applicant's co-pending U.S. patent application Ser. No.15/385,729, titled “Method and Apparatus for Neuromodulation Treatmentsof Pain and Other Conditions”, filed Dec. 20, 2016.

Patient attachment device 70 can comprise one or more elementsconfigured to attach one or more external devices 500 and/or programmer550 at one or more locations on or proximate the patient's skin, thatare relatively close to one or more implantable devices 200/800 thathave been implanted in the patient. Patient attachment device 70 cancomprise a component selected from the group consisting of: belt; beltwith pockets; belt with adhesive, adhesive; strap; strap with pockets;strap with adhesive shoulder strap; shoulder band; shirt; shirt withpockets; clothing; clothing with pockets; epidural electronicspackaging; clip; bracelet; wrist band; wrist watch; anklet; anklebracelet; knee strap; knee band; thigh strap; thigh band; necklace; hat;headband; collar; glasses; goggles; earpiece; behind-the-earpiece; andcombinations of one or more of these. In some embodiments, patientattachment device 70 comprises a belt configured to surround at leastone antenna 540 (e.g. at least one antenna 540 a and/or 540 b mounted toor otherwise positioned on a printed circuit board such as a flexibleprinted circuit board). Patient attachment device 70 can include one ormore pockets, such as one or more pockets configured to collectivelysurround one or more of: external device 500; programmer 550; one ormore antennas 540; power supply 570; power supply 557; and combinationsof one or more of these. In some embodiments, patient attachment device70 comprises multiple pockets, such as to allow repositioning of anexternal antenna 540, programmer 550, external transmitter 530, powersupply 570, and/or power supply 557 to various different locations, suchas to improve transmission of power and/or data to one or moreimplantable devices 200/800 and/or to improve patient comfort. In someembodiments, one or more antennas 540, power supplies 570, powersupplies 557, transmitters 530, and/or transmitters 553 are connectedthrough flexible cables positioned in patient attachment device 70. Insome embodiments, the flexible cables are small coax cables that canaccommodate the power levels and frequencies of the carried signals. Insome embodiments, the one or more antennas 540 are connected to one ormore additional components of external device 500 and/or programmer 550through a single cable with a local power splitting component and/oractive matching element that adjusts signal power to each of the one ormore antennas 540.

In some embodiments, one or more implantable devices 200/800 ofimplantable system 20 can comprise an implantable transmitter configuredto transmit data, such as to transmit data (e.g. stimulationinformation, patient physiologic information, patient environmentinformation, implantable device 200/800 performance and/or configurationinformation, and the like) to one or more external devices 500 and/orprogrammer 550. In these embodiments, receiver 230/830 can be configuredas both a receiver and a transmitter. One or more implantable devices200/800 can be configured to transmit data by sending a signal to (i.e.“driving”) one or more antennas 240/840 or another antenna ofimplantable device 200/800. An implantable device 200/800 can beconfigured to transmit data using one or more of: load modulation; asignal carrier; and/or body conduction. An implantable device 200/800can be configured to adjust the transmission, such as to adjust a datatransmission parameter selected from the group consisting of: data rate;pulse width; duration of carrier signal; amplitude of carrier signal;frequency of carrier signal; configurable load; and combinations of oneor more of these.

In some embodiments, apparatus 10 comprises a diagnostic assembly,diagnostic assembly 91 shown in FIG. 1 . In some embodiments, programmer550 and/or implantable controller 250/850 comprise all or a portion ofdiagnostic assembly 91. Diagnostic assembly 91 can be configured toassess, monitor, determine and/or otherwise analyze patient informationand/or implantable device 200/800 information, such as when one or morestimulation elements 260 or functional elements 299/599/899 areconfigured as a sensor that records patient information (e.g. patientphysiologic information and/or patient environment information) and/orapparatus 10 information (e.g. implantable device 200/800 information)as described herein. Diagnostic assembly 91 can be configured to analyzecommunication and/or the power link between an implantable device200/800 and an external device 500. In some embodiments, such acommunication link analysis can be performed by measuring bit error rate(BER) of a known data stream during communication signal transmission(also referred to as “communication link”) measurement phase (e.g. suchas during a calibration procedure). The BER can be tracked by thecontroller 250/850 or programmer 550, such as to monitor and keep trackof any trends in the link. This trend can be used to adjust the linkand/or provide feedback to an operator of apparatus 10 (e.g. thepatient), in case the link cannot be automatically adjusted tocompensate for a negative trend (e.g. such that the operator can performphysical re-adjustment of the external system 50). Alternatively oradditionally, a power link analysis can be performed by monitoringcharge/discharge rate of the implanted energy storage assembly 270/870.Similar to the communication link, the power link status and/or trendingcan be monitored and recorded for link adjustment and/or feedbackpurposes. Diagnostic assembly 91 can be configured to analyze a resultof stimulation energy delivered by implantable device 200/800, such aswhen a stimulation element 260 comprises an electrode to recordelectrical activity of tissue (e.g. in addition to delivering electricalenergy to stimulate tissue). A stimulation element 260 and/or functionalelement 299/599/899 can comprise a sensor configured to record neuralactivity and/or muscular activity, and diagnostic assembly 91 can beconfigured to analyze the recorded sensor data. In some embodiments,diagnostic assembly 91 can be configured to analyze impedance, such aswhen a stimulation element 260 and/or a functional element 299/599/899comprises a sensor configured to record data related to impedance, suchas when implantable device 200/800 performs a frequency sweep, performsan impulse response and/or compares voltage and current of a stimulationwaveform. In some embodiments, diagnostic assembly 91 is configured toassess the impedance of one or more implantable antennas 240/840 and/orone or more external antennas 540. In these embodiments, impedance canbe assessed by performing a function selected from the group consistingof: performing a frequency sweep; performing an impulse response;comparing voltage and current of a waveform; and combinations of one ormore of these.

In some embodiments, diagnostic assembly 91 is configured to test orotherwise assess the link between one or more implantable antennas240/840 and one or more external antennas 540 (e.g. during a procedurein which one or more implantable devices 200/800 are implanted in apatient). In these embodiments, diagnostic assembly 91 can be configuredto perform a test prior to anchoring housing 210/810 to tissue (e.g.prior to initial or final suturing into tissue such as the fascialayer). For example, lead 265 can be implanted at a location tostimulate target tissue (e.g. one or more nerves identified to treatpain or another patient condition). Prior to suturing housing 210/810 inits implant location, diagnostic assembly 91 can be configured toconfirm that one or more external antenna 540 transmission links to oneor more implantable antennas 240/840 are above an efficiency threshold,for example such that sufficient power will be received by the one ormore implantable devices 200/800. Additionally, the procedure can beperformed to optimize or otherwise improve the position of the one ormore implantable devices 200/800 to be implanted and subsequentlysecured to tissue.

In these link testing embodiments, diagnostic assembly 91 can comprise ahandheld assembly (e.g. a sterile assembly comprising a wand or otherhandheld housing). Diagnostic assembly 91 can be configured to send asimple signal to one or more implantable devices 200/800 (e.g. adiagnostic assembly 91 with similar power and/or data transmissioncapabilities as an external device 500). Each implantable device 200/800can respond (e.g. via data sent via an implantable antenna 240/840 orother transmitter) with information related to the quality of thetransmission link (e.g. information about the power received by the oneor more implantable devices 200/800). Diagnostic assembly 91 couldprovide a user interface (e.g. a speaker, a text screen and/or a videodisplay) that provides quality or other information (go/no goinformation, digital or other discrete level information, and/or analoginformation). Diagnostic assembly 91 could be further configured toprovide information confirming detection of one or more implantabledevices 200/800, status of one or more implantable devices 200/800 (e.g.parameter level and/or fault detection status), and/or self-diagnosticstatus (i.e. diagnostic assembly 91 status).

Each implantable device 200/800 can be configured to specificallyidentify and/or specifically reply to diagnostic assembly 91 (e.g. in adifferent form than communications with an external device 500). Eachimplantable device 200/800 can be configured to provide informationrelated to one or more of: the charge and/or discharge rate of energystorage assembly 270/870 (e.g. the charge and/or discharge rate of acapacitor or battery of energy storage assembly 270/870); or thefrequency of a voltage-controlled oscillator that is driven by anunregulated voltage of a power converter of receiver 230/830. Diagnosticassembly 91 can be configured to perform numerous performance tests(e.g. of one or more implantable devices 200/800 or implantationlocations for one or more implantable devices 200/800), prior tocompletion of the implantation procedure (e.g. prior to closing one ormore incisions).

In some embodiments, implantable system 20 of apparatus 10 is configuredto perform magnetic field modulation, such as targeted magnetic fieldneuromodulation (TMFN), electro-magnetic field neuromodulation, such astargeted electro-magnetic field neuromodulation (TEMFN), transcutaneousmagnetic field stimulation (TMS), or any combination of these. Eachimplantable device 200/800, via one or more of its stimulation elements260 (e.g. electrodes) can be configured to provide localized (e.g.targeted) magnetic and/or electrical stimulation. Combined electricalfield stimulation and magnetic field stimulation can be applied by usingsuperposition, and can reduce the overall energy requirement. In someembodiments, implantable apparatus 10 comprises one or more stimulationelements 260 comprising a magnetic field generating transducer (e.g.microcoils or cuff electrodes positioned to partially surround orotherwise be proximate to one or more target nerves). Stimulationelements 260 comprising microcoils can be aligned with nerves tominimize affecting non-targeted tissue (e.g. to avoid one or moreundesired effects to non-target tissue surrounding or otherwiseproximate the target tissue). In some embodiments, the target tissuecomprises dorsal root ganglia (DRG) tissue, and the non-target tissuecomprises ventral root tissue (e.g. when the stimulation energy is belowa threshold that would result in ventral root tissue stimulation).

In some embodiments, external system 50 of apparatus 10 is configured toprovide mechanically adjustable alignment of one or more externalantennas 540 alignment. Link gain between one or more external antennas540 and one or more implantable antennas 240/840 can degrade over timedue to physical misalignment of the antennas, relative orientationchange between antennas and/or relative angular misalignment betweenantennas. In order to compensate for misaligned antennas, electricalbeam steering can be included in apparatus 10. Antennas comprising amulti-feed antenna structure and/or an array of antennas can beincorporated (e.g. into external antenna 540, implantable antenna240/840 or both) for electrical beam steering. Alternatively oradditionally, mechanical antenna steering can be implemented tophysically realign one or more external antennas 540 with one or moreimplanted antennas 240/840 (or vice versa). A substrate of animplantable antenna 240/840 and/or an external antenna 540 can beflexible and/or rigid (e.g. a substrate comprising polyamide, polyimide,liquid crystal polymer (LCP), Rogers, FR4, or a similar material). Oneor more antennas 540 can be connected to electronics (e.g. atransmitter, receiver or transceiver) using a flexible waveguide orcable (e.g. 50 ohm 0.047″ coaxial cable designed to provide patientcomfort) and/or a flexible PCB substrate transmission line. Mechanicalor physical realignment of antennas 240/840 and/or 540 can beaccomplished using one or more of: use of motorized positioners, such asa mechanism including one or more small pulleys and/or tensioners usedto translate one or more antennas 240/840 and/or 540 about one or moreaxes; an actuator (e.g. a piezoelectric actuator) with directional gearsconfigured to translate one or more antennas 240/840 and/or 540 aboutone or more axes; a micro-pump with fluid reservoir (e.g. liquid or gasreservoir) configured to hydraulically and/or pneumatically translateone or more antennas 240/840 and/or 540 about one or more axes, such asby creating a local pressure difference. In some embodiments, amicro-pump with fluid reservoir can be used to move one or more antennas240/840 and/or 540, such as to move an external antenna 540 away fromtissue to reduce specific absorption rate (SAR). In these embodiments,external antenna 540 can be positioned in mechanical contact with anexpandable reservoir (e.g. a balloon) positioned between externalantenna 540 and tissue. The reservoir can be inflated or deflated tocontrol separation distance of the external antenna 540 from thepatient's skin surface. In some embodiments, apparatus 10 comprises oneor more algorithm positioning algorithms, beam steering functionalityand/or mechanical antenna steering as described in applicant'sco-pending U.S. patent application Ser. No. 14/975,358, titled “Methodand Apparatus for Minimally Invasive Implantable Modulators”, filed Dec.18, 2015, or International PCT Patent Application Serial NumberPCT/US2016/016888, titled “Medical Apparatus including an ImplantableSystem and an External System”, filed Feb. 5, 2016, the content of eachof which is incorporated herein in its entirety for all purposes.

In some embodiments, implantable system 20 of apparatus 10 is configuredto provide paresthesia-reduced (e.g. paresthesia-free) high frequencypain management and rehabilitation therapy (e.g. via delivery of astimulation signal above 600 Hz or 1 kHz, or other stimulation signalresulting in minimal paresthesia). Apparatus 10 can be configured toprovide both low frequency (e.g. <1 kHz) stimulation and high frequencystimulation, such as when providing low frequency stimulation to elicitfeedback from a patient during intraoperative or other (e.g.post-implantation) stimulation configuration. For example, programmer550 and/or an external device 500 can be used during an intra-operativetitration of stimulation configuration using low frequency stimulation(e.g. to position and/or confirm position of one or more stimulationelements 260, such as to confirm sufficient proximity to target tissueto be stimulated and/or sufficient distance from non-target tissue notto be stimulated). In some embodiments, high frequency stimulation isdelivered to reduce pain over extended periods of time, and lowfrequency stimulation is used in these intraoperative and/orpost-implantation titration or other stimulation configurationprocedures. Intentional elicitation of paresthesia (e.g. via lowfrequency stimulation and/or high frequency stimulation) is beneficialduring stimulation element 260 (e.g. electrode) implantation because apatient can provide feedback to the implanting clinician to ensure thatthe stimulation elements 260 are positioned close to the targetneuromodulation or energy delivery site. This implantationposition-optimizing procedure can advantageously reduce the requiredstimulation energy due to stimulation elements 260 being closer totarget tissue, since a minimum threshold for efficacious stimulationamplitude is proportional to the proximity of stimulation elements 260to target tissue (e.g. target nerves). The patient can inform theclinician of the sensation of paresthesia coverage, and the cliniciancan adjust stimulation element 260 position to optimize stimulationelement 260 location for efficacious treatment while minimizingunintentional stimulation of non-target tissue (e.g. motor nerves orother nerves which are not causing the patient's pain). Theseparesthesia-inducing techniques (e.g. using low frequency stimulationand/or high frequency stimulation) can be used during or afterimplantation of one or more implantable devices 200/800.

In some embodiments, apparatus 10 is configured to deliver low frequencystimulation energy (e.g. electrical energy comprising a low frequencysignal provided by implantable device 200 and/or implantable device 800)to stimulate motor nerves, such as to improve tone and structuralsupport (e.g. physical therapy). In these embodiments, apparatus 10 canbe further configured to provide high frequency stimulation, such as totreat pain (e.g. suppress and/or control pain). The combined effect canbe used not only for pain management but also muscle strengthening andgradual healing of supportive structures. Alternatively or additionally,as described herein, apparatus 10 can be configured to deliver lowfrequency stimulation energy (e.g. electrical energy) to induceparesthesia, which can also be accompanied by the delivery of highfrequency stimulation (e.g. to suppress and/or control pain). In someembodiments, apparatus 10 is configured to deliver low frequencystimulation (e.g. electrical energy comprising a low frequency signal)and burst stimulation, delivered simultaneously or sequentially. The lowfrequency stimulation and the burst stimulation can be delivered onsimilar and/or dissimilar stimulation elements 260 (e.g. similar ordissimilar electrode-based stimulation elements 260).

Apparatus 10 can be configured to treat neuropathy, neuralgia and/orother nerve pain that is related to: surgery; trauma; infection (e.g. aherpetic infection); and/or diabetes (e.g. diabetic neuropathy). One ormore stimulation elements 260 can be configured to deliver stimulationenergy (e.g. electrical energy, magnetic energy, light energy, thermalenergy, sound energy, and/or chemical energy (e.g. energy from a drug orreagent) to nerve tissue such as tissue of the central nervous systemand/or peripheral nervous system. One or more leads 265 (each comprisingone or more stimulation elements 260) can be implanted in and/orproximate the spinal cord, the groin and/or a joint such as the hip. Forexample, apparatus 10 can be configured to treat one or more of:post-surgical neuralgia (e.g. following hernia repair such as a herniarepair including an implanted mesh); headache (e.g. due to occipitalneuralgia); post-herpetic neuralgia; chronic pelvic and/or hip pain;knee pain; and combinations of one or more of these.

To treat pain related to hernia or hernia repair, one or morestimulation elements 260 (e.g. on a lead 265 and/or on a housing 210)can be positioned to stimulate tissue of the peripheral nervous systemand/or the central nervous system. In some embodiments, one or morestimulation elements 260 are positioned to stimulate the cutaneousbranch of the ilioinguinal, inguinal and/or genital branch of thegenitofemoral nerves. In some embodiments, one or more stimulationelements 260 are positioned to stimulate corresponding branches ofspinal nerves correlating to one or more dermatomes related to painassociated with at least one of hernia or hernia repair. Hernia orhernia repair can lead to: inguinal pain; ilioinguinal neuralgia;post-traumatic neuropathic pain; ilioinguinal nerve entrapment;neuropathic pain of ilioinguinal origin; post-surgical inguinal pain;genitofemoral pain; genitofemoral neuralgia; genitofemoral nerveentrapment; neuropathic pain of genitofemoral origin; post-surgicalgenitofemoral pain; iliohypogastric pain; iliohypogastric neuralgia;iliohypogastric nerve entrapment; neuropathic pain of iliohypogastricorigin; post-surgical iliohypogastric pain; testicular pain; scrotalpain; penis pain; groin pain; thigh pain; anal pain; rectal pain;perineal pain; abdominal adhesions; pelvic adhesions; scar pain; diffusepolyneuropathy; and combinations of one or more of these. In someembodiments, apparatus 10 is configured to treat hernia pain bydelivering a low frequency stimulation signal (e.g. an electrical signalless than or equal to 1 kHz delivered by one or more electrode-basedstimulation elements 260). Alternatively or additionally, apparatus 10can treat hernia pain with a high frequency stimulation signal, such asa signal comprising a frequency greater than 1 kHz. Stimulation can beaccomplished either via subcutaneous field stimulation and/or bystimulation elements 260 positioned adjacent or at least near the nervesand/or their branches. In some embodiments, stimulation is accomplishedtransvascularly (e.g. stimulation including low and/or highfrequencies).

The apparatus of the present inventive concepts can be configured tostimulate the ilioinguinal nerve, genitofemoral nerve and/oriliohypogastric nerves, such as to ameliorate pain following herniarepair. One or more leads 265 (e.g. one or more leads 265 comprising oneor more electrode-based or otherwise stimulation-based stimulationelements 260) can be inserted over the inguinal region (which mayinclude the inguinal ring) to stimulate any or all three of these nerves(e.g. in a unilateral or bilateral fashion). Both the ilioinguinal andgenital branch of the genitofemoral nerves pass through the inguinalring. The anterior cutaneous iliohypogastric and femoral branch of thegenitofemoral nerve can be stimulated at one or more locations proximatebut rostral (iliohypogastric) or lateral (genitofemoral) to the inguinalring. Leads 265 can comprise one or more stimulation elements 260comprising cylindrical, paddle, cuff and/or hemi-cuff electrodes(electrodes placed surgically near and/or around these nerves). Thenerves can be localized via ultrasound or other imaging modalities.Contrast can be used to image the vessels nearby (e.g. the testicularand/or ovarian vein and/or artery). The genital branch of thegenitofemoral nerve can be stimulated in a transvascular manner throughthe testicular vein and/or artery. The genitofemoral and/or theilioinguinal nerves can also be stimulated (e.g. transvascularlystimulated) through the femoral vein and/or artery, or via thesuperficial or deep external pudendal vein and/or artery, and/or via thesuperficial epigastric vein and/or artery.

The painful areas innervated by the ilioinguinal nerve, genitofemoralnerve and/or iliohypogastric nerves, can also be treated via spinal cordstimulation provided by apparatus 10 in the L1-L5 region of the spinalcord. In some embodiments, direct stimulation of the L1-L2 dorsal rootganglia is provided in a similar treatment. Leads 265 (e.g. percutaneousor paddle) including stimulation-based stimulation elements 260 can beplaced over the dorsal columns, over the dorsal roots and/or in thedorsal root entry zone, in a unilateral, bilateral and/or midlinefashion.

To treat occipital neuralgia, also known as C2 neuralgia, one or morestimulation elements 260 can be positioned to stimulate peripheral nervetissue to reduce pain. Occipital neuralgia is a medical conditioncharacterized by chronic pain in the upper neck, back of the head and/orbehind the eyes (areas corresponding to the locations of the lesser andgreater occipital nerves). In some embodiments, one or more leads 265,each comprising one or more stimulation elements 260, can be implantedtransversely, either unilaterally or bilaterally, at the level of theappropriate target cervical nerve (C1, C2, etc.). The C1, C2, C3cervical roots include the greater occipital nerve which originatesprimarily from C2, and the lesser occipital nerves. Relevant trigeminalbranches include both the supraorbital and supratrochlear nerves fromV1, the infraorbital branches from V2, and the superficial temporalnerves from V3. A partial convergence of these two systems occurs at theTrigemino-Cervical Complex (TCC). In some embodiments, one or morestimulation elements 260 are positioned to stimulate the trigeminaland/or occipital nerves. One or more leads 265 can be anchored to thefascia proximate the tissue to be stimulated.

To treat post-herpetic neuralgia (e.g. neuralgia associated withshingles), one or more stimulation elements 260 can be positioned tostimulate corresponding branches of the spinal nerves correlating to oneor more dermatomes related to the patient's shingles.

In some embodiments, apparatus 10 is configured to treat pelvic, bladderand/or bowel disorders, such as by stimulating sacral, pudendal and/ortibial nerves. In some embodiments, apparatus 10 is configured to treatpelvic pain by stimulating the tibial nerve.

Apparatus 10 can be configured to treat a bladder, bowel or otherdysfunction selected from the group consisting of: overactive bladder;urinary urgency; urinary frequency; urinary urgency frequency; urinaryurge incontinence; urinary stress incontinence; urge incontinence;stress incontinence; non-obstructive urinary retention; female sexualdysfunction; fecal incontinence; constipation; diarrhea; irritable bowelsyndrome; colitis; detrusor instability; detrusor dysfunction; spasticbladder; neurogenic bladder; detrusor sphincter dyssynergia; detrusorhyperreflexia; detrusor areflexia; and combinations of one or more ofthese.

Apparatus 10 can be configured to treat a pelvic disorder selected fromthe group consisting of: pelvic pain; painful bladder syndrome; Hunner'sulcers or lesions; interstitial cystitis; pelvic floor dysfunction;endometriosis; vulvodynia; dyspareunia; pelvic adhesions; abdominaladhesions; irritable bowel syndrome; pelvic girdle pain; pudendal nerveentrapment; pudendal neuralgia; dysmenorrhea; Müllerian abnormalities;pelvic inflammatory disease; ovarian cysts; ovarian torsion; Loin painhematuria syndrome; proctitis; prostatitis; prostadynia; post-abdominalsurgical pain; post-pelvic surgical pain; hernia pain; post-herniasurgical pain; anal pain; rectal pain; perineal pain; groin pain; vulvarpain; vaginal pain; clitoral pain; colitis; and combinations of one ormore of these.

Apparatus 10 can be configured to treat one or more of the pelvicdisorders, bladder dysfunctions and/or and bowel dysfunctions listedabove, by stimulating (e.g. using bilateral and/or unilateralstimulation) one or more of the targets listed below.

In some embodiments, the stimulated targets include the sacral nerves(roots) S2, S3 and/or S4. One or more leads 265 (e.g. each including oneor more stimulation-delivering stimulation elements 260) can bepositioned to stimulate any or all of the three roots, on a single sideor both sides, in any bilateral or unilateral combination. The roots canbe accessed, with the patient lying in the prone position, bypositioning one or more leads 265 (e.g. percutaneously), with or withoutthe use of fluoroscopy, ultrasound or any other imaging modality, intoone/any of the sacral foramen(a) from the posterior aspect of thesacrum. One or more leads 265 can be passed through the foramen to theanterior side of the sacrum, and/or one or more leads 265 can remaininside the foramen(a).

In some embodiments, the sacral roots are approached rostrally, via thesacral canal in a retrograde manner. In these embodiments, one or moreleads 265 can be passed through the ligamentum flavum, just caudal to L5or via any of the intervertebral spaces from L5 to T12, into the spinalcanal. One or more leads 265 are then threaded, with or without the aidof visualization (fluoroscopy, ultrasound or other imaging modality), ina caudal (retrograde) manner to enter the sacral canal. One or moreleads 265 can be placed along the sacral canal, and each root can bestimulated individually and/or each root can be stimulated in concert,via one or more leads 265 positioned along the internal surface of thesacral canal, and spanning one or more foramina.

In some embodiments, one or more leads 265 are threaded from the spinalcanal into each and/or all sacral foramen(a), in an anterior direction.The sacral canal can also be accessed caudally by one or more leads 265,via the sacral hiatus in an anterograde manner.

In some embodiments, the sacral roots (S2, S3 and/or S4) are accessed asthey enter the spinal cord at the cauda equina. This access can beachieved by inserting the one or more leads 265 through the ligamentumflavum, at a location just caudal to L5, or via any of theintervertebral spaces from L5 to T12, into the spinal canal. The one ormore leads 265 can then be threaded, with or without the aid ofvisualization (fluoroscopy, ultrasound or other imaging modality), up tothe cauda equina, where the S2, S3 and/or S4 roots can be stimulatedwhere they enter the spinal cord, and/or the conus medullaris can bestimulated directly (e.g. in the same location).

In some embodiments, the pudendal nerve is stimulated through one ormore different approaches. The pudendal nerve contains both afferent andefferent fibers carried by S2, S3 and S4 roots. The pudendal fibers exitAlcock's canal near the ischial spine, where they spread out toinnervate to the bladder wall, perineum, anus, genitals and urethra.Pelvic and voiding disorders can be treated by stimulating pudendalnerve fibers. The fibers can be accessed at the Alcock's canal viavarious approaches. In one embodiment, a transperineal approach isachieved by positioning the patient in the lithotomy position andinserting the lead 265 midpoint between the ischial tuberosity and theanus. A lead 265 is inserted toward the ischial spine, which can bepalpated transvaginally or transrectally. The ischial spine can also bevisualized through a number of imaging modalities (e.g. fluoroscopy,x-ray, ultrasound, and the like). In another embodiment, a transvaginalapproach is achieved by positioning the patient in the lithotomyposition and inserting a lead 265 through the vaginal wall, adjacent tothe ischial spine (e.g. through the vaginal wall toward the ischialspine). In another embodiment, a posterior approach is achieved bylaying the patient in the prone position and inserting a lead 265 justmedial to the ischial tuberosity toward the ischial spine. Thisinsertion can be facilitated by rectal palpation of the ischial spineand through visualization via a number of imaging modalities (e.g.fluoroscopy, x-ray, ultrasound, and the like).

In some embodiments, apparatus 10 is configured to stimulate pudendalafferents, such as by stimulating the dorsal genital nerve. These fibersare located just below the skin on the dorsum of the penis or justrostral to the clitoris. In some embodiments, pudendal afferents arestimulated periurethrally. One or more leads 265 can be insertedalongside the urethra to stimulate the pudendal fibers.

In some embodiments, apparatus 10 is configured to stimulate tibialnerve fibers, such as to treat one or more pelvic disorders (e.g.voiding dysfunction). The tibial nerve can be accessed a few mm belowthe skin surface in the ankle immediately posterior to the medialmalleolus. Lead 265 can comprise a cylindrical SCS-type lead, which canbe inserted percutaneously in this location. Alternatively oradditionally, a direct (surgical) cut-down can be used to insert acylindrical lead or to apply a cuff electrode directly to the nerve. Thetibial nerve can also be accessed approximately half way up the lowerleg adjacent to the tibia. One or more leads 265 can be insertedpercutaneously in this location. Alternatively or additionally, a directcut-down can be used to insert lead 265 (e.g. a cylindrical lead or acuff electrode and/or hemi-cuff electrode applied directly to the nervein the mid-shin location). Tibial nerve fibers can be accessed in thepopliteal fossa behind the knee, for example percutaneously with a lead265 comprising a cylindrical lead, and/or via a direct cut-down, forexample with a lead 265 comprising either a cylindrical or cuffelectrode.

In some embodiments, apparatus 10 and one or more leads 265 areconstructed and arranged to stimulate the tibial and/or pudendal nervesvia a transvascular approach (i.e. stimulation energy delivered frominside a blood vessel to nerve tissue proximate the blood vessel), suchas via the femoral vein and/or artery, each of which provideintraluminal access to many other blood vessels (e.g. using standardinterventional techniques). The tibial nerve can be transvascularlystimulated by the popliteal vein and/or artery (e.g. by placing one ormore stimulation elements 260 in the popliteal vein and/or artery), at alocation behind the knee. The popliteal vein and/or artery can beintraluminally accessed from the femoral artery and vein. The tibialnerve also passes near the small saphenous vein, where it branches offof the popliteal vein. The posterior tibial vein and/or artery arepositioned adjacent to the tibial nerve, from the knee to the foot. Oneor more leads 265 can utilize one or more of these above locations tostimulate the tibial nerve.

In some embodiments, apparatus 10 and one or more leads 265 areconstructed and arranged to stimulate the pudendal nerve and/or sacralroots, such as using a lead 265 placed via the femoral vein and/orartery, which in turn provides intraluminal access to many vessels. Oneor more leads 265 can be configured to utilize any of the followingarteries and veins to stimulate the pudendal nerve and/or the sacralroots. One or more leads 265 can be constructed and arranged tostimulate a target site via a blood vessel selected from the groupconsisting of: the internal pudendal artery or vein (which branch off ofcommon iliac artery or vein, respectively); the inferior and superiorgluteal vein and/or artery; middle rectal, pudendal plexus and internaliliac vein and/or artery; medial and lateral sacral vein and/or artery;uterine and obturator vein and/or artery; and combinations of one ormore of these.

In some embodiments, apparatus 10 is configured to treat pelvicdysfunction, overactive bladder, and/or urinary incontinence (singly orcollectively “overactive bladder” herein). In some embodiments,apparatus 10 is configured to treat overactive bladder such as to reducethe effects of overactive bladder and/or to decrease use of one or moremedications taken by the patient to treat overactive bladder. In someembodiments, one or more stimulation elements 260 are positioned tostimulate tissue of the central nervous system or tissue and/or tissueof the peripheral nervous system to treat overactive bladder, such as tostimulate one or more nerves that control and/or are otherwise relatedto bladder function (e.g. to increase bladder capacity, improve bladderemptying, reduce urge incontinence and/or reduce stress incontinence).For example, one or more stimulation elements 260 can be positioned tostimulate tibial nerve tissue and/or sacral nerve tissue (e.g. at leastthe S3 nerve root) to treat overactive bladder. In some embodiments,lead 265 is constructed and arranged to be positioned along one or morelocations of the tibial nerve, such as a positioning performed usingpercutaneous technique (e.g. when lead 265 comprises a cylindricalSCS-type lead) and/or surgical (cut-down) techniques (e.g. when lead 265comprise a cuff electrode and/or hemi-cuff electrode applied directly tothe nerve). The tibial nerve branches off of the sciatic nerve justabove the knee, and runs along the length of the tibia, medial andlateral to the tibia. The tibial nerve then passes posterior to themedial malleolus prior to innervating the plantar surface of the foot.Lead 265 can be constructed and arranged to access sites proximate thetibial nerve percutaneously and/or through an incision at the back ofthe knee in the popliteal fossa, along the tibia or behind the medialmalleolus. The housing 210/810 can be placed anywhere in the leg whenstimulating the tibial nerve. Lead 265 can be constructed and arrangedto stimulate the tibial nerve through a transvascular approach, via thefemoral vein and/or artery, each of which provide intraluminal access tomany vessels. The tibial nerve can be accessed by the popliteal arteryand vein behind the knee, which are intraluminally accessible from thefemoral artery and vein, respectively. The tibial nerve also passes nearthe small saphenous vein, where it branches off of the popliteal vein.The posterior tibial vein and artery travel adjacent to the tibial nervefrom the knee to the foot. One or more leads 265 can be constructed andarranged to utilize any of these locations to transvascularly stimulatethe tibial nerve (e.g. transvascularly stimulate the tibial nerve viathe popliteal artery, popliteal vein, saphenous vein, posterior tibialartery and/or posterior tibial vein via a lead 265 advanced via thefemoral vein and/or artery). In these transvascular embodiments, thehousing 210/810 can be placed near the femoral or popliteal access pointat locations in the groin, perineum, scrotum, pelvis, hip, thigh, leg,behind the knee, buttocks, abdomen and/or low back. In the case ofsacral nerve stimulation, one or more leads 265 can be inserted throughan incision(s) made in the lower back, such that one or more stimulationelements 260 are positioned proximate (e.g. in contact) with the sacralnerve root(s). The housing 210/810 can be placed anywhere in the groin,perineum, scrotum, pelvis, hip, thigh, leg, behind the knee, buttocks,abdomen and/or low back. Lead 265 (e.g. a lead 265 comprising a leadextension) can be extended underneath the skin (e.g. tunneled) to asecond incision (e.g. across the flank to the lower abdomen, across themidline to the buttocks, or low back), and a third incision can be made(e.g. in the abdomen, back or buttocks) where housing 210/810 can beinserted and connected to lead 265 (e.g. via port 290/890 as describedherein). Alternatively, housing 210/810 can be inserted at anotherinternal location. If lead 265 is already connected (e.g. attached inmanufacturing) to housing 210/810, lead 265 can be advanced in theopposite direction, such as from the third incision, to the secondincision, to the first incision (if three incisions are made), orhousing 210/810 can be advanced under the tissue from incision 1 toincision 2 or from incision 2 to incision 3. In some embodiments, only 1or 2 incisions are performed. In some embodiments, such as when lead 265is already connected (e.g. attached in manufacturing) to housing 210,lead 265 and housing 210/810 are implanted. In some embodiments, a firstlead 265 and a first housing 210/810 (pre-attached or attachable) areutilized in a dose titration or other “trialing procedure” (e.g. duringa trial period of the present inventive concepts), and a second lead 265and housing 210/810 (pre-attached or attachable) are implanted in thepatient for subsequent treatment of the patient (e.g. during a therapyperiod of the present inventive concepts).

In some embodiments, one or more stimulation elements 260 are positionedto perform posterior tibial nerve stimulation (PTNS), also referred toas percutaneous tibial nerve stimulation, such as to perform an indirectform of neuromodulation to treat bladder voiding dysfunction. Theposterior tibial nerve is derived from the lumbar-sacral nerves (L4-S3),which innervate the bladder detrusor and pelvic floor. In someembodiments, one or more stimulation elements 260 can be positioned toperform retrograde stimulation of the sacral nerve plexus and restorethe balance between bladder inhibitory and excitatory control systems ofthe bladder. One or more stimulation elements 260 can be positionedabove the ankle, proximate and/or into the tibial nerve. Implantabledevice 200/800 can deliver stimulation energy to the stimulationelements 260 comprising low-voltage electrical stimulation configured toproduce sensor and/or motor responses. Apparatus 10 can be configured toprovide continuous and/or intermittent stimulation to tissue, such as tomodulate transmission of excitatory nerve signals to the bladdermuscles. In some embodiments, implantable system 20 is configured todeliver a series of repeated stimulation periods, such as a regimen ofapproximately weekly thirty minute sessions of stimulation for twelveweeks. In some embodiments, implantable system 20 is configured toprovide daily or hourly sessions that deliver stimulation for between 10minutes and 60 minutes. In some embodiments, apparatus 10 is configuredto achieve an approximate 50% reduction in urinary urge incontinenceand/or urinary urgency/frequency episodes.

In some embodiments, apparatus 10 is configured to provide temporarystimulation therapy of tissue to treat overactive bladder, such as byusing one or more external devices 500, such as to provide power and/ordata to one or more implantable devices 200/800 to confirm acceptableimprovement of the patient's overactive bladder (e.g. successfulstimulation of one or more sacral nerves, tibial nerves or othertissue), before closing an incision or otherwise fully implanting one ormore implantable devices 200/800. In some embodiments, a temporarystimulation therapy is provided for: up to one week, up to one month,more than 1 month, more than 2 months, or more than 3 months. In someembodiments, one or more implantable devices 200/800 are left in placeif the temporary stimulation therapy period is successful orunsuccessful (e.g. left implanted due to its small size or otherwiseminimal impact on the patient).

In some embodiments, apparatus 10 is configured to stimulate a region ofthe pelvic floor, such as to: change the reflex thresholds of thebladder muscles responsible for bladder emptying, strengthen and/orotherwise improve the condition of the muscles that maintain closure onthe bladder outlet; change the state of the neural pathways, musculatureand/or bladder during and beyond the period stimulation; and/orotherwise decrease the severity of urinary incontinence. In someembodiments, one or more stimulation elements 260 are positioned tostimulate periurethral muscles. In some embodiments, one or morestimulation elements 260 are positioned to stimulate tissue of thevagina or anus. In some embodiments, one or more stimulation elements260 are positioned to stimulate sphincter muscles for controlling thebladder, such as two stimulation elements 260 positioned on either sideof the urethral orifice. In these embodiments, housing 210/810 can beimplanted in suprapubic region or in the perineum. In some embodiments,lead 265 comprises (e.g. on a distal portion) a pessary ring comprisingtwo stimulation elements 260. In some embodiments, stimulation elements260 comprise periurethral electrodes configured to stimulate pudendalafferents.

As described above, apparatus 10 can be configured for treating numerousdiseases, disorders or other undesirable patient conditions, such asfecal incontinence. Injury of nerves that sense stool in the rectum canlead to fecal incontinence. In some embodiments, one or more stimulationelements 260 (e.g. one or more electrical, magnetic, light or otherenergy delivery elements) of one or more leads 265 and/or one or moreimplantable devices 200/800 are configured to stimulate tissue to treatfecal incontinence, such as to treat tissue selected from the groupconsisting of: sacral nerve tissue; tissue whose stimulation strengthensmuscles of the bowel and/or rectum; and combinations of one or more ofthese. In these fecal incontinence applications, leads 265 can beimplanted in a location selected from the group consisting of: thepelvic girdle; the sacral foramina; the lower back; the upper buttock;and combinations of one or more of these, such as to stimulate sacralnerve tissue. Leads 265 can be anchored via lead anchors (silicone orother materials), suture, staples, clips, adhesive and the like, such asan attachment to the underlying fascia of target tissue to bestimulated. In some embodiments, apparatus 10 is configured to treatboth fecal incontinence and a bladder disorder such as overactivebladder, such as when one or more stimulation elements 260 areconfigured to deliver energy to sacral nerve or other tissue.

In some embodiments, apparatus 10 is configured to treat fecalincontinence, overactive bladder (i.e. overactive bladder and/or urinaryincontinence), and/or pelvic disorders, and implantable device 200:comprises between 1 and 16 stimulation elements 260, such as four ormore electrodes; delivers electrical stimulation energy at a range ofapproximately between 10 Hz and 15 Hz (or a range of between 5 Hz and 25Hz); delivers electrical stimulation energy with a pulse width ofapproximately between 180 μsec and 240 μsec (or between 1 μsec and 200μsec); provides electrical stimulation energy with an amplitude ofapproximately 0.1V to 8.5V (e.g. providing a current between 0.1 mA to10 mA, which can be adjusted in increments between 0.01 mA and 0.1 mA),such as an amplitude between 0.4V and 2.0V; delivers continuouselectrical stimulation energy; delivers intermittent electricalstimulation energy, such as with a period between 8 seconds and 24seconds and/or an on time between 8 seconds and 16 seconds; or an ontime of several hours followed by an off time of several hours (such as8 hours of stimulation ON and 16 hours of stimulation OFF or 16 hours onand 8 hours off, and 12 hour on and 12 hours off); delivers monopolarelectrical energy; delivers bipolar electrical energy; and combinationsof one or more of these.

In some embodiments, apparatus 10 is configured to treat an occipitalneuralgia, such as migraine headache, headache and/or cluster headache,and one or more stimulation elements 260 (e.g. small column paddleelectrodes, standard paddle electrodes or other electrodes) arepositioned to stimulate nerve tissue selected from the group consistingof: occipital; supraorbital; infraorbital; greater occipital nerve(GON); lesser occipital nerve (LON); both supraorbital and GON;supratroclear; sphenopalantine (SPG); and combinations of one or more ofthese.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia resulting from surgery (e.g. groin, shoulder, lung and/oramputation), trauma and/or phantom pain, and one or more stimulationelements 260 are positioned to stimulate nerve tissue.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia resulting from groin surgery (e.g. hernia or other groinsurgery), and one or more stimulation elements 260 are positioned tostimulate nerve tissue selected from the group consisting of:ilioinguinal; genitofemoral; iliohypogastric; and combinations of one ormore of these.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia resulting from shoulder surgery, and one or morestimulation elements 260 are positioned to stimulate axial nerve tissue(e.g. one or more stimulation elements 260 positioned on a lead 265implanted in a suprascapular location).

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia resulting from lung surgery, and one or more stimulationelements 260 are positioned to stimulate intercostal nerve tissue.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia associated with carpal tunnel syndrome, and one or morestimulation elements 260 are positioned to stimulate median nervetissue.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a neuralgia associated with temporomandibular joint disorder (TMJ),and one or more stimulation elements 260 are positioned to stimulate V2of trigeminal nerve tissue.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a facial neuralgia, and one or more stimulation elements 260 arepositioned to stimulate trigeminal nerve tissue.

In some embodiments, apparatus 10 is configured to treat neuralgia, suchas a leg (sciatic) neuralgia, and one or more stimulation elements 260are positioned to stimulate nerve tissue proximal a contributing lesion.

In some embodiments, apparatus 10 is configured to treat pelvic pain,such as interstitial cystitis and/or bladder pain, and one or morestimulation elements 260 are positioned to stimulate peripheral nervoussystem tissue (e.g. pudendal tissue and/or S-2, S-3 and/or S-4 roots)and/or central nervous system tissue (e.g. lower spinal cord and/or S3neural foramen).

In some embodiments, apparatus 10 is configured to treat pelvic pain,such as anal pain, and one or more stimulation elements 260 arepositioned to stimulate peripheral nerve tissue such as pudendal tissueand/or S-2, S-3 and/or S-4 roots.

In some embodiments, apparatus 10 is configured to treat subcutaneouspain, and one or more stimulation elements 260 (e.g. paddle electrodes)are positioned to stimulate nerve tissue.

In some embodiments, apparatus 10 is configured to treat diabeticneuropathy, such as painful diabetic neuropathy, and one or morestimulation elements 260 are positioned proximate the lower spinal cord(e.g. to stimulate S3 nerves) or other body location to stimulate nervetissue.

In some embodiments, apparatus 10 is configured to treat visceral pain,angina and/or other pain, and one or more stimulation elements 260 arepositioned to stimulate the vagus nerve.

In some embodiments, apparatus 10 is configured to treat peripheralvascular disease, diabetic neuropathy and/or other conditions associatedwith diabetes, such as to treat a disease or disorder selected from thegroup consisting of: peripheral diabetic neuropathic pain; painfuldiabetic peripheral neuropathy; peripheral vascular disease; peripheralarterial disease; peripheral artery disease; cardiac autonomicneuropathy; diabetic autonomic neuropathy; diabetic sensory neuropathy;diabetic motor neuropathy; diabetic sensorimotor neuropathy; diabeticmuscular atrophy; diabetic neurovascular disease; and combinations ofone or more of these. In these embodiments, lead 265 can be positionedproximate a nerve in the foot, leg, arm and/or sacrum (e.g. such thatone or more stimulation elements 260 are positioned proximate the nerveto be stimulated). In some embodiments, lead 265 is positioned tostimulate the dorsal root ganglia to treat diabetic neuropathy (e.g.diabetic neuropathy of the hand and/or foot). Lead 265 can be implantedpercutaneously and/or surgically as described herein. Lead 265 and/orone or more stimulation elements 260 can comprise a paddle electrode,such as one or more paddle electrodes implanted in the foot, leg and/orarm. Lead 265 and/or one or more stimulation elements 260 can comprise acuff or hemi-cuff electrode surgically implanted around a nerve in thefoot, leg and/or arm. Apparatus 10 can be configured to provide spinalcord stimulation, either through percutaneous insertion of one or moreleads 265 in the epidural space or surgical implantation of a lead 265comprising a paddle lead positioned in the epidural space. Apparatus 10can be configured to provide transvascular stimulation of nerves in thefoot, leg and/or arm, (e.g. to treat diabetic neuropathy) such as whenone or more leads 265 are interventionally advanced into the venous orarterial system. Leads 265 can be positioned using percutaneoustransforaminal placement in the sacral foramina, such as for treatmentof foot or leg disorders. Leads 265 can be constructed and arranged forcephalocaudal insertion (retrograde) into the epidural space or sacralcanal, such as for treatment of foot or leg disorders. Leads 265 can beconstructed and arranged to provide dorsal root ganglion stimulation,such as for treatment of trunk, neck, head, back, foot, leg, arm and/orhand disorders.

One or more leads 265 (e.g. each including one or more stimulationelements 260) can be constructed and arranged to stimulate tibial nervefibers, such as to treat diabetic neuropathy and/or diabetic relatedmaladies of the foot. The tibial nerve can be accessed as describedherein.

One or more leads 265 can be configured to stimulate the peroneal nerveor saphenous nerve, such as at one or more locations describedherebelow. The peroneal nerve can be accessed percutaneously orsurgically behind the knee in the popliteal fossa where it branches offof the sciatic nerve. It can also be accessed as it wraps around thelateral aspect of the knee just prior to diving under the fibularislongus and extensor digitorum longus muscles. The deep fibular nerve (abranch of the peroneal nerve) innervates top medial foot, whereas thesuperficial fibular (peroneal) innervates top of both medial and lateralfoot. In some embodiments, stimulation element 260 comprises one or moreelectrodes positioned in the anterior tibial vein and/or artery totransvascularly stimulate the deep fibular nerve. The saphenous nervecomes off the femoral nerve deep in the thigh. It passes around themedial aspect of the knee medial to the patella. It then runs down themedial shin adjacent to the tibia, gastrocnemius and soleus muscleswhere it can be accessed surgically or percutaneously. It then surfacesjust as it warps around the anterior aspect of the medial malleoluswhere it supplies the medial posterior foot in front of heel. The medialsural cutaneous nerve comes off of the tibial at the popliteal fossa,then runs down the back of the calf (over the gastrocnemius) and wrapsaround the posterior aspect of the lateral malleolus before innervatingthe lateral aspect of the sole and heel. In some embodiments, thesaphenous nerve is transvascularly stimulated by positioning one or morestimulation elements 260 in a blood vessel selected from the groupconsisting of: femoral vein; femoral artery; great saphenous vein; greatsaphenous artery; and combinations of one or more of these. In someembodiments, the sural nerve is stimulated. In these embodiments, thesural nerve can be transvascularly stimulated by positioning one or morestimulation elements 260 in the saphenous vein.

One or more leads 265 can be configured to stimulate the median nerve,ulnar nerve and/or radial nerve. The median nerve can be accessedpercutaneously in the upper arm lateral to the brachial vein and/orartery, but medial to the biceps muscle, whereas the ulnar nerve runsmedial to the brachial artery in the upper arm. The median nerve passesthrough the anterior aspect of the elbow under the bicipitalaponeurosis. The ulnar nerve runs medial and posterior to the medialepicondyle of the humerus. The median nerve can also be accessed in thewrist just proximal to the palm and the palmar carpal ligament. Theulnar nerve can be accessed just proximal to the palmar carpal ligamentadjacent to the pisiform. The radial nerve can be accessedpercutaneously just as it passes anterior to the lateral epicondyle. Insome embodiments, apparatus 10 can be configured to transvascularlystimulate at least one of a median nerve, an ulnar nerve or a radialnerve, and stimulation element 260 can comprise one or more electrodespositioned in a vessel selected from the group consisting of: brachialvein; brachial artery; basilic vein; basilic artery; deep vein of thearm; deep artery of the arm; and combinations of one or more of these.In some embodiments, apparatus 10 can be configured to transvascularlystimulate at least one of a median nerve or an ulnar nerve, andstimulation element 260 can comprise one or more electrodes positionedin a vessel selected from the group consisting of: brachial vein;brachial artery; and combinations of one or more of these. In someembodiments, apparatus 10 can be configured to transvascularly stimulatethe radial nerve, and stimulation element 260 can comprise one or moreelectrodes positioned in a vessel selected from the group consisting of:deep vein of arm; deep artery of arm; basilic vein; radial collateralvein; radial collateral artery; medial collateral vein; medialcollateral artery; radial vein; radial artery; and combinations of oneor more of these. In some embodiments, apparatus 10 can be configured totransvascularly stimulate the medial cutaneous nerve, and stimulationelement 260 can comprise one or more electrodes positioned in thebasilic vein. In some embodiments, apparatus 10 is configured totransvascularly stimulate the ulnar nerve, and stimulation element 260can comprise one or more electrodes positioned in a vessel selected fromthe group consisting of: ulnar collateral vein; ulnar collateral artery;ulnar vein; ulnar artery; and combinations of one or more of these. Insome embodiments, apparatus 10 is configured to transvascularlystimulate the median nerve, and stimulation element 260 can comprise oneor more electrodes positioned in a vessel selected from the groupconsisting of: brachial vein; brachial artery; ulnar vein; ulnar artery;and combinations of one or more of these.

As described herein, one or more leads 265 can be positioned tostimulate the spinal cord, such as via percutaneous insertion of a lead265 in the epidural space or surgical implantation of the lead 265 (e.g.a paddle lead) in the epidural space. A lead 265 can be placed such thatone or more stimulation elements 260 (e.g. one or more electrodes) arepositioned from T5-S5, such as to capture the area of pain or reducedcirculation of the leg or foot. One or more stimulation elements 260 ofone or more leads 265 can be positioned from C2 to T8, such as tocapture the area of pain or reduced circulation of the arm or hand. Oneor more leads 265 can be placed along the midline, unilaterally and/orbilaterally over the dorsal columns, in the gutter (over dorsal roots)and/or in the dorsal root entry zone. Leads 265 can span severalvertebral levels or they can be positioned to span a single level.

One or more stimulation elements 260 (e.g. one or more electrodesattached to one or more leads 265) can be positioned to transvascularlystimulate one or more nerves, such as one or more nerves in the foot,leg and/or arm, such as when the one or more stimulation elements 260are implanted within one or more blood vessels of the venous and/orarterial system.

In the leg, the tibial nerve, sacral roots and/or deep fibular nerve canbe stimulated, such as when a lead 265 accesses the tissue to bestimulated through a transvascular approach, such as via the femoralvein and/or artery, as described herein. The deep fibular nerve can bestimulated by one or more stimulation elements 260 positioned in theanterior tibial vein and/or the anterior tibial artery. In the arm, themedian nerve, ulnar nerve, superior ulnar nerve, medial cutaneous nerveand/or radial nerve can be stimulated, such as when lead 265 accessesthe tissue to be stimulated through a transvascular approach, such asvia the brachial vein and/or artery, the basilic vein and/or artery,and/or the deep vein and/or artery.

One or more stimulation elements 260 (e.g. one or more electrodesattached to one or more leads 265) can be positioned to stimulate dorsalroot ganglia that supply the following nerves (e.g. to treat the legand/or foot): common peroneal (L4-S2); tibial (L4-S3); femoral (L2-L4);and combinations of one or more of these. One or more stimulationelements 260 (e.g. one or more electrodes attached to one or more leads265) can be positioned to stimulate dorsal root ganglia that supply thefollowing nerves (e.g. to treat the hand and/or arm): radial (C5-T1);median (C5-T1); ulnar (C7-T1); and combinations of one or more of these.In these embodiments, one or more leads 265 can be passed through theintervertebral foramina, either unilaterally or bilaterally, at a singlevertebral level or at multiple vertebral levels.

In some embodiments, apparatus 10 is configured to treat post-amputationpain, such as to treat a disease or disorder selected from the groupconsisting of: phantom limb pain; phantom stump pain; acute andpersistent stump pain; limb pain; neuroma; Morton's neuroma;neurilemoma; neurolemoma; Schwann cell tumor; phantom limb itch; phantomlimb sensations; and combinations of one or more of these. Apparatus 10can be configured to treat the conditions associated withpost-amputation pain (i.e. stump pain), such as by using a highfrequency alternating current (HFAC) block approach. In theseembodiments, one or more leads 265 can be implanted such that one ormore stimulation elements 260 stimulate one or more nerves in the leg,arm and/or sacrum. One or more leads 265 can be surgically implanted,such as when lead 265 comprises a paddle electrode positioned near anerve in the foot, leg or arm and/or a cuff electrode or hemi-cuffelectrode positioned to at least partially surround a nerve in the foot,leg or arm. One or more leads 265 can be positioned to stimulate thespinal cord, such as via a percutaneous insertion of the leads 265 inthe epidural space or surgical implantation of the lead 265 (e.g. apaddle lead) in the epidural space. One or more leads 265 can bepositioned to provide transvascular stimulation of nerves in the leg orarm, such as when one or more stimulation elements 260 are implantedwithin a vein or artery. One or more leads 265 can be implanted usingpercutaneous transforaminal placement in the sacral foramina, such asfor treatment of leg stump pain. One or more leads 265 can be implantedusing cephalocaudal insertion (retrograde) into the epidural space orsacral canal, such as for treatment of leg stump pain. One or more leads265 can be positioned to perform dorsal root ganglion stimulation and/orblock, such as for treatment of leg and/or arm stump pain.

In some embodiments, apparatus 10 is configured to treat occipitaland/or headache (HA) pain, such as when apparatus 10 is configured totreat a disease or disorder selected from the group consisting of:occipital neuralgia; cervicogenic headache; tension headache; chronicand episodic migraine headache; hemicrania continua; trigeminalautonomic cephalalgias (TACs); chronic and episodic cluster headache;chronic and episodic paroxysmal hemicranias; short-lasting unilateralneuralgiform headache attacks with conjunctival injection and tearing(SUNCT); short-lasting unilateral neuralgiform headache attacks withcranial autonomic symptoms (SUNA); long-lasting autonomic symptoms withhemicrania (LASH); post-traumatic headache; and combinations of one ormore of these.

Apparatus 10 can be configured to treat the conditions associated withheadache pain and/or occipital neuralgia by stimulating one or morenerves in the head, such as one or more nerves selected from the groupconsisting of: greater and/or lesser occipital nerve (e.g. which arisefrom C2 and C3); the greater and/or lesser auricular nerves (e.g. whichalso arise from C2/C3); the third (least) occipital nerve (e.g. whicharises from C3); and combinations of one or more of these. Theinfraorbital or supraorbital nerves can be access subcutaneously belowand above the eye, respectively. Apparatus 10 can be configured tostimulate auriculotemporal, supratrochlear and/or sub-occipital nerves.To stimulate any of these nerves, lead 265 (e.g. a cylindrical SCS-typelead) can be inserted percutaneously either subcutaneously or under themuscle. Alternatively, surgical (e.g. direct cut-down) can be performedto insert lead 265 (e.g. a cylindrical lead, a paddle lead, a cuff orhemi-cuff electrode) proximate, one and/or around these nerves.Alternatively or additionally, the nerves can be accessedtransvascularly as described herein (e.g. when one or more stimulationelements 260 are implanted in a blood vessel). Housing 210/810 can beimplanted anywhere in the head under the skin, including: behind theear, back of the head, the neck, in the face, and the like, where an oneor more external devices 500 can be positioned in, on and/or within ahat, headband, glasses, goggles, earpiece, necklace, patch, and thelike. Apparatus 10 can be configured to treat headache pain and/oroccipital neuralgia by stimulating tissue in the cervical spinal cord(C2-C3), for example proximate the location the nerve enters the cordfrom the foramen. One or more leads 265 can be placed over the dorsalcolumns, in the gutter, over the dorsal root entry zone and/or out inthe foramen at the dorsal root ganglion. In some embodiments, thetrigeminal and pterygopalatine ganglia are accessed by inserting one ormore leads 265 through the face or the roof of the mouth. In theseembodiments, housing 210/810 can be placed anywhere in the head underthe skin, as described herein.

In some embodiments, apparatus 10 is configured to treat post-herpeticneuralgia, such as to treat a disease or disorder selected from thegroup consisting of: shingles; herpes zoster; zoster; zona; varicellazoster virus infection; zoster sine herpete; fever blisters; herpeszoster blisters; herpes zoster rash; and combinations of one or more ofthese. In some embodiments, apparatus 10 is configured to treatpost-herpetic neuralgia using high frequency alternating current (HFAC)block approach. In these embodiments, one or more leads 265 can beimplanted such that one or more stimulation elements 260 stimulate oneor more nerves in the leg, arm, torso and/or sacrum. One or more leads265 can be surgically implanted, such as when lead 265 comprises apaddle electrode positioned near a nerve in the foot, leg, torso and/orarm and/or a cuff electrode or hemi-cuff electrode positioned to atleast partially surround a nerve in the foot, leg, torso or arm. One ormore leads 265 can be positioned to stimulate the spinal cord, such asvia a percutaneous insertion of the leads 265 in the epidural space orsurgical implantation of the lead 265 (e.g. a paddle lead) in theepidural space. One or more leads 265 can be positioned to providetransvascular stimulation of nerves in the leg, torso and/or arm, suchas when one or more stimulation elements 260 are implanted within a veinor artery. One or more leads 265 can be implanted using percutaneoustransforaminal placement in the sacral foramina, such as for treatmentof leg or foot pain. One or more leads 265 can be implanted usingcephalocaudal insertion (retrograde) into the epidural space or sacralcanal, such as for treatment of leg or foot pain. One or more leads 265can be positioned to perform dorsal root ganglion stimulation and/orblock, such as for treatment of leg, torso and/or arm pain.

In some embodiments, apparatus 10 is configured to treat angina, such asto treat a disease or disorder selected from the group consisting of:angina; chest pain caused by reduced blood flow to the heart muscle;chest pain associated with coronary artery disease such as squeezing,pressure, heaviness, tightness or pain in the chest; recurring anginapectoris; acute angina pectoris; chronic angina pectoris; acute coronarysyndrome; chest pain; coronary artery spasms; microvascular angina;Prinzmetal's angina; angina inversa; stable or common angina; unstableangina; variant angina; and combinations of one or more of these.

In some embodiments, apparatus 10 is configured to treat carpal tunnelsyndrome, such as to treat a disease or disorder selected from the groupconsisting of: median nerve entrapment; tingling and/or numbness infingers or hand; median nerve irritation or compression; narrowing ofthe carpal tunnel; and combinations of one or more of these. In theseembodiments, apparatus 10 can be configured to deliver stimulation tomedian nerve tissue; ulnar nerve tissue and/or radial nerve tissue.

In some embodiments, apparatus 10 is configured to treat erectiledysfunction (ED), such as to treat a disease or disorder selected fromthe group consisting of: impotence; male sexual dysfunction; inabilityto develop or maintain an erect penis; cardiogenic ED; vasculogenic ED;diabetic ED; neurogenic ED; traumatic ED; post-prostatectomy ED;hormonal ED; hyopogonadism; pharmacological ED; and combinations of oneor more of these.

In some embodiments, apparatus 10 is configured to treat complexregional pain syndrome (CRPS), such as to treat a disease or disorderselected from the group consisting of: CRPS type 1; CRPS type 2; reflexsympathetic dystrophy; causalgia; reflex neurovascular dystrophy;amplified musculoskeletal pain syndrome; systemic autonomicdysregulation; neurogenic edema; musculoskeletal pain; and combinationsof one or more of these.

In some embodiments, apparatus 10 is configured to treat knee pain. Kneepain from joint degeneration or join replacement surgery can be treatedvia stimulation of the nerves innervating the knee and/or viastimulation of the tissue surrounding the knee (sometimes referred to asperipheral field stimulation). Apparatus 10 can comprise between one andeight leads 265 whose stimulation elements 260 are placed near andaround the knee. In some embodiments, four leads 265 are placed, inlocations medial, lateral, superior and inferior to the knee. The leads265 can be placed subcutaneously for field stimulation, or they can beplaced directly adjacent to specific nerve targets. Applicable nervetargets are as follows: medial knee can include medial femoral cutaneousand infrapatellar cutaneous branches of saphenous nerve; lateral kneecan include constant articular branches of common peroneal, lateralretinacular nerve; anterior knee can include lateral, medial, andanterior cutaneous femoral nerve, infrapatellar branch of saphenousnerve, medial and lateral retinacular nerve and articular branches ofperoneal nerve; posterior knee can include obturator, posterior tibialand sciatic nerves. In addition, the following nerves can be stimulatedvia stimulation elements 260 to treat knee pain: nerves arising from thetibial nerve such as the superior, middle and inferior genicular nerves;nerves arising from the common peroneal such as the superior lateral,inferior lateral, and recurrent genicular nerves; and nerves arisingfrom the obturator nerve such as the genicular branch of obturator; andnerves arising from the femoral nerve such as the saphenous nerve. Eachof these targets can be stimulated transvascularly by one or morestimulation elements 260.

In some embodiments, one or more implantable devices 200/800 areconfigured to deliver stimulation energy (e.g. via one or morestimulation elements 260 comprising an electrode) with a stimulationwaveform comprising one or more high frequency signals (e.g. a signalcomprising one or more high frequency components). For example, one ormore implantable devices 200/800 can deliver one or more stimulationwaveforms comprising one or more signals above 600 Hz, such as one ormore signals above 1.0 kHz, 1.2 kHz, 5 kHz, 10 kHz or 25 kHz. In theseembodiments, the delivered stimulation waveform can be configured to bevoid of (i.e. not include) one or more lower frequency signals, such asby not including any signals at a frequency below 100 Hz, below 500 Hz,below 1000 Hz, below 1200 Hz or below 1500 Hz.

One or more implantable devices 200/800 can be configured to deliverstimulation energy with a stimulation waveform that varies over time. Insome embodiments, one or more stimulation parameters of the stimulationwaveform are randomly varied over time, such as by using a probabilitydistribution as described in applicant's co-pending applicationInternational PCT Patent Application Serial Number PCT/US2017/017978,titled “Apparatus with Enhanced Stimulation Waveforms”, filed Feb. 15,2017. Each stimulation waveform can comprise one or more pulses, such asa group of pulses that are repeated at regular and/or irregularintervals. In some embodiments, a pulse can comprise delivery ofelectrical energy, such as electrical energy delivered in one or morephases (e.g. a pulse comprising at least a cathodic portion and ananodic portion). In some embodiments, single or groups of pulses areprovided at time-varying modes of repetition (e.g. regular intervals fora period, then a period of irregular intervals) or at regular intervalswith occasional (random) spurious pulses inserted (creating a singleirregular event in an otherwise regular series). Non-limiting examplesof waveform variations include: a variation in frequency (e.g. frequencyof one or more signals of the waveform); variation of a signalamplitude; variation of interval time period (e.g. at time periodbetween pulses or a time period between pulse trains); variation of apulse width; multiple piecewise or continuous variations of one of morestimulation parameters in a single pulse (e.g. multi-step,multi-amplitude in one “super-pulse”); variation of pulse symmetry (e.g.via active drive, passive recovery and/or active-assisted passiverecovery); variation of stimulation energy over a time window and/oroverlapping time windows; variation of the power in the frequencyspectrum of the stimulation waveform; and combinations of one or more ofthese. In some embodiments, apparatus 10 and/or implantable device200/800 can be configured to vary a stimulation waveform“systematically” such as a variation performed temporally (e.g. onpredetermined similar or dissimilar time intervals) and/or a variationperformed based on a parameter, such as a measured parameter that can bebased on a signal produced by a sensor of implantable device 200/800 oranother component of apparatus 10 (e.g. one or more of functionalelement 299/599/899). Alternatively or additionally, apparatus 10 and/orimplantable device 200/800 can be configured to vary a stimulationwaveform randomly. Random variation shall include discrete or continuousvariations that can be selected from a distribution, such as aprobability distribution selected from the group consisting of: auniform distribution; an arbitrary distribution; a gamma distribution; anormal distribution; a log-normal distribution; a Pareto distribution; aGaussian distribution; a Poisson distribution; a Rayleigh distribution;a triangular distribution; a statistic distribution; and combinations ofone or more of these. Random pulses or groups of pulses can be generatedbased on randomly varying one or more stimulation signal parameters asdescribed herein. One or more stimulation parameters can be variedrandomly through the use of one or more probability distributions, asdescribed herebelow.

In some embodiments, the amplitude of a signal delivered by one or moreimplantable devices 200/800 is adjusted to prevent discomfort to thepatient (e.g. paresthesia or other undesired condition) from thestimulation signal. In some embodiments, the amplitude of thestimulation signal can be ramped (e.g. up and/or down), a single time ormultiple times (e.g. continuously or intermittently). In someembodiments, a titration procedure can be performed (e.g. the trialperiod of the present inventive concepts) to “set” one or morestimulation parameters based on avoiding patient discomfort.

In some embodiments, one or more implantable devices 200/800 areconfigured to deliver stimulation energy (e.g. via one or morestimulation elements 260 comprising an electrode) with a stimulationwaveform comprising one or more waveforms configured to one or morespecific conditions of a patient. Each stimulation waveform can comprisea series of continuous pulses, intermittent pulses, and/or spuriouspulses (e.g. occasional events in an otherwise continuous stream). Eachpulse can comprise a pulse train that is repeatedly delivered byimplantable device 200/800, the train comprising one or more cathodicpulses and/or one or more anodic pulses. In some embodiments,implantable device 200/800 delivers a multiphasic pulse comprising atleast two cathodic pulses and/or anodic pulses, with or without any timebetween each pulse. For example, implantable device 200/800 can delivera biphasic pulse comprising a cathodic pulse followed by an anodicpulse, a triphasic pulse comprising a cathodic pulse followed by ananodic pulse followed by a second cathodic pulse, or any series of twoor more cathodic and/or anodic pulses. In some embodiments, deliveredpulses are exponential in nature (e.g. comprise an exponential portion),such as dynamic return pulses that exceed a minimum current (e.g. atleast 1 mA, 10 mA or 50 mA) for a short duration (e.g. for approximately1 μsec), and then decay to lower current levels (e.g. a level ofapproximately 100 nA), with a time constant on the order of 1 μsec to100 μsec.

The stimulation waveforms delivered by implantable device 200/800 cancomprise one or more high frequencies (e.g. as described herein). Thestimulation waveform frequency or other stimulation parameter can be setand/or adjusted (hereinafter “adjusted”) to optimize therapeutic benefitto the patient and minimize undesired effects (e.g. paresthesia or otherpatient discomfort). In some embodiments, a stimulation waveform isadjusted based on a signal produced by a sensor of apparatus 10 (e.g. asensor of implantable device 200/800, such as a stimulation element 260or functional element 299/899 configured as a sensor). Adjustment of astimulation waveform parameter can be performed automatically by theimplantable device 200/800 and/or via an external device 500 and/orprogrammer 550.

In some embodiments, a pulse shape of a stimulation waveform can bevaried, such as a pulse shape comprising: a sinusoidal geometry; asquare geometry (e.g. a waveform comprising a square wave); arectangular geometry; a triangular geometry; (e.g. symmetric orasymmetric); a trapezoidal geometry; a sawtooth geometry; a rampedgeometry; an exponential geometry; a piece-wise step function geometry;a root-raised cosine geometry; and combinations of one or more of these.

In some embodiments, a charge recovery phase (e.g. anodal phase) of astimulation waveform is varied by implantable device 200/800.

Inter-pulse gap, the time between one or more pulses (e.g. a biphasic orother multiphasic pulse that is repeated continuously), can be variedsystematically and/or randomly by implantable device 200/800. In someembodiments, inter-pulse gap between one or more pulses comprises zerotime (i.e. a first pulse is immediately followed by a similar ordissimilar second pulse). In some embodiments, inter-pulse gap is variedsystematically, such as on a routine basis (i.e. temporally) and/orvaried based on a signal produced by a sensor of apparatus 10.Alternatively or additionally, inter-pulse gap can be varied randomly.such as a random variation based on a distribution (e.g. a probabilitydistribution with a pre-determined shape) as described herebelow.

In some embodiments, implantable device 200/800 delivers a stimulationwaveform comprising a series of frequency modulated (FM) pulses, suchthat the frequency of stimulation varies. Implantable device 200/800 canbe configured to deliver a frequency modulated stimulation waveformcomprising a carrier signal, at a carrier frequency, that is modulatedcontinuously between a first frequency and a second frequency. Forexample, implantable device 200/800 can deliver a stimulation waveformthat modulates between 2.0 kHz and 3.0 kHz every second (e.g. comprisinga carrier signal at 2.5 kHz that is modulated at 1 Hz) with a modulationrange (the excursion from the carrier signal) of +/−500 Hz. In someembodiments, implantable device 200/800 can deliver a stimulationwaveform that comprises: a carrier frequency between 1 kHz and 50 kHz, amodulation frequency between 0.1 Hz and 10 kHz and/or a modulation rangebetween 1 Hz and the carrier frequency.

In some embodiments, implantable device 200/800 delivers a stimulationwaveform comprising a series of amplitude modulated (AM) pulses, suchthat the amplitude of stimulation varies (e.g. varying the amplitude ofthe voltage and/or current of the stimulation signal). The amplitude ofdelivered current can be varied in a single amplitude modulated sweep,such as a sweep from 2 mA to 3 mA. In some embodiments, amplitude of asignal can be varied continuously, such as when current is variedbetween 2 mA and 3 mA every second (e.g. a signal comprising amodulation frequency of 1 Hz). In these embodiments, the depth ofmodulation would be 33%, where depth of modulation is equal to 1−[lowerrange/upper range]. In some embodiments, amplitude of delivered currentfluctuates between 1 mA and 3 mA (i.e. a depth of modulation of 66%),while in other embodiments, current fluctuates between 0 mA and 3 mA(e.g. a depth of modulation of 100%). In some embodiments, implantabledevice 200/800 is configured to deliver an amplitude modulated signalcomprising: a carrier frequency between 1 Khz and 50 kHz; a modulationfrequency between 0.1 Hz and the carrier frequency and/or a depth ofmodulation between 0.1% and 100%.

In some embodiments, implantable device 200/800 delivers a stimulationwaveform comprising delivery of continuously balanced analog currentwaveforms, for example from a differential Howland current source. Inthese embodiments, there are not independent pulses, but rather there istrue analog frequency and amplitude modulation. Periods of deliveringstimulation (or presence of balanced differential analog stimulation)and periods of no stimulation (e.g. a quiescent period) can be included.In some embodiments, controller 250/850 comprises one or morereconfigurable stimulation blocks including one or more Howland or othercurrent sources. The one or more current sources (e.g. two or morecurrent sources) can each be attached to a stimulation element 260 (e.g.in a monopolar configuration when the current source is also connectedto housing 210/810 or in a bipolar configuration when the current sourceis connected to a pair of stimulation elements 260). Alternatively,controller 250/850 can comprise one or more current sources that areattached to a matrix of switches that selectively connect the one ormore current sources to multiple stimulation elements 260 (e.g. connecta single current source to 2, 4, 8, 12 or 16 electrodes). In someembodiments, controller 250/850 is configured such that a stimulationwaveform signal provided to the current source passes through acapacitor (e.g. capacitor C1 shown), the capacitor providing DC balance.

In some embodiments, implantable device 200/800 delivers a stimulationwaveform comprising delivery of multiple trains of pulses that aredelivered intermittently, a “burst stimulation” waveform as definedhereabove. For example, implantable device 200/800 can be configured todeliver a series or train of five pulses, each with a 1 msec pulsewidth, and each of the five pulses can be separated by an inter-pulsegap of 4 msec, creating a train-on period of 16 msec. These five pulsescan be repeated every 25 msec (the “inter-train period”). In someembodiments, implantable device 200/800 can be configured to deliver aburst stimulation waveform comprising a pulse width between 5 μsec and 1msec. Implantable device 200/800 can deliver a train or burststimulation waveform comprising pulses with constant pulse widths and/orvarying pulse widths, such as when the pulse widths (and/or otherstimulation parameters) are varied randomly and/or systematically.Implantable device 200/800 can deliver a train or burst stimulationwaveform with a varied or constant pulse shape selected from the groupconsisting of: sinusoid; square, rectangle; triangle (symmetric orasymmetric); trapezoid; sawtooth; ramp (e.g. a linear ramp); exponentialcurve; piece-wise step function; and combinations of one or more ofthese. Implantable device 200/800 can deliver a train or burststimulation waveform with an inter-pulse gap less than inter-trainperiod. The inter-pulse gap can be relatively constant or it can bevaried, such as when implantable device 200/800 randomly varies theinter-pulse gap or varies the inter-pulse gap systematically. In someembodiments, the inter-pulse gap between any two pulses within a pulsetrain (or burst) can be varied between 0.1 μsec and the inter-trainperiod (or inter-burst period). Implantable device 200/800 can deliver atrain stimulation waveform with an inter-pulse gap between 1 μsec and 1second. Implantable device 200/800 can deliver a burst stimulationwaveform with an inter-train period between 1 μsec and 1 second.Implantable device 200/800 can deliver a burst stimulation waveform withan inter-burst period between 20 μsec and 24 hours. The inter-burstperiod can be relatively constant or it can be varied, such as whenimplantable device 200/800 randomly varies the inter-burst period orvaries the inter-burst period systematically. In some embodiments,inter-burst period is varied by the user, such as via a user usingprogrammer 550. In these embodiments, user activation can be regulatedwith one or more safeguards or other limits such as those incorporatedinto patient controlled analgesia devices. The inter-train period can bevaried between 1 μsec and 24 hours. Implantable device 200/800 candeliver a train or burst stimulation waveform with a train-on period(the time between the onset of a first pulse in a pulse train to the endof the last pulse in a pulse train) between 10 μsec and 24 hours. Thetrain-on and/or burst-on period can be relatively constant or it can bevaried, such as when implantable device 200/800 randomly varies thetrain-on and/or burst-on period or varies the train-on and/or burst-onperiod systematically. Implantable device 200/800 can deliver a train orburst stimulation waveform with a train or burst envelope selected fromthe group consisting of: cosine; cosine-squared; sine; square;rectangle; triangle (symmetric or asymmetric); trapezoid: sawtooth; ramp(e.g. linear ramp); and combinations of one or more of these.Implantable device 200/800 can deliver a train and/or burst stimulationwaveform with a train ramp duration or burst ramp duration between 1μsec to 10 minutes. Implantable device 200/800 can deliver a trainand/or burst stimulation waveform with a depth of modulation betweentrain and/or bursts of between 1% and 99%. For example, between some orall of the trains and/or bursts (burst-off or train-off periods), asignal may be present and may contain the same or different elementscontained in the train-on and/or burst-on period. These burst-off ortrain-off periods may comprise a quiescent period as described herein.The amplitude of the signal contained in these quiescent period may befrom 0% to 99% of the signal amplitude during the train-on and/orburst-on period, such as a signal with an amplitude less than 50% of thesignal amplitude during the train-on and/or burst-on period or anotheramplitude below a neuronal excitation threshold.

In some embodiments, apparatus 10 is configured to deliver stimulationenergy to dorsal root ganglion and/or spinal cord tissue to treat acondition such as pain. In these and other embodiments, apparatus 10 canbe configured to provide a stimulation waveform comprising: acombination of low frequency stimulation (e.g. electrical energycomprising a low frequency signal) and burst stimulation; burststimulation (e.g. burst stimulation alone); a combination of lowfrequency stimulation and high frequency stimulation; a combination oflow frequency stimulation, high frequency stimulation and burststimulation; and combinations of one or more of these. The stimulationenergy provided by apparatus 10 can be delivered to tissue via one ormore stimulation elements 260, such as two or more electrodes whichdeliver similar or dissimilar stimulation waveforms simultaneouslyand/or sequentially. Each of the stimulation waveforms can comprise oneor more pulses comprising an entire phase or at least a portion of aphase at a superthreshold level. Alternatively or additionally, each ofthe stimulation waveforms can comprise one or more pulses comprising anentire phase or at least a portion of a phase at a subthreshold level.

In some embodiments, apparatus 10 is configured to vary one or morestimulation parameters to optimize (e.g. balance the benefits of):therapeutic benefit, system efficiency, stimulation efficiency,avoidance and/or reduction of paresthesia, and/or reduction of charge.

In some embodiments, implantable device 200/800 comprise a filament(e.g. a flexible filament comprising one or more wires, optical fibers,wave guides, and the like), conduit 298/898, which extends from housing210/810 as shown in FIG. 1A. Port 290/890 is positioned on an end ofconduit 298/898. As described above, lead 265 can be operably attachedto implantable device 200/800 via port 290/890 in one or more clinicalprocedures (e.g. a first clinical procedure in which lead 265 isattached to implantable device 200 at port 290 of conduit 298 and asubsequent second clinical procedure in which lead 265 is attached toimplantable device 800 at port 890 of conduit 898, such as is describedherein in reference to FIGS. 1 and/or 2 ). Lead 265 is shown prior toattachment to port 290/890 in FIG. 1A. A tool, tool 61, can be includedto assist in the attachment of lead 265 to port 290/890, such as tool 61described herebelow.

In some embodiments, implantable device 200/800 comprises both conduit298/898, and a sleeve, collar or other attachment element, fitting 266,which is used to create a seal, seal 267, between lead 265 and port290/890. In FIG. 1B, lead 265 has been connected to port 290/890, andfitting 266 has been positioned about the connection, such as to createseal 267. Seal 267 can be configured to prevent significantcontamination from interfering with the operable connection (e.g. toprevent shorting of contacts, preventing loss or degradation of anelectrical, optical and/or acoustic connection, and/or prevent anotherundesired effect). In some embodiments, implantable system 20 does notinclude fitting 266, and a seal is provided between one or more portionsof lead 265 and implantable device 200/800. Fitting 266 and/or seal 267can be configured to significant contamination for a limited period oftime (e.g. seal 267 comprises a “temporary seal”), for example less than1 week, less than one month, less than 2 months, and/or less than 3months, such as when fitting 266 and/or seal 267 is present for alimited period of time (e.g. a limited period of time in whichimplantable device 200 and corresponding attachment port 290 areattached to lead 265 during a trial period as described herein).

Referring now to FIG. 1C, a schematic view of two implantable devices isillustrated, the first implantable device comprising a pre-attached leadand the lead comprising a removable portion, consistent with the presentinventive concepts. Implantable device 200 and implantable device 800can be of similar construction and arrangement to those describedhereabove in reference to FIG. 1 . Lead 265 is shown attached toimplantable device 200, such as a permanent attachment made in amanufacturing process of implantable device 200. In some embodiments,one or more gaskets, gasket 296 shown, is used to seal lead 265 tohousing 210. Lead 265 comprises one or more stimulation elements 260(e.g. electrodes), which are operably connected to one or more internalcomponents of implantable device 200 via conduit 263. Implantable device200 and attached lead 265 can be implanted in the patient, such as toperform a trialing procedure of the present inventive concepts.

Lead 265 can comprise a removable distal portion 264, such thatdetachment of distal portion 264 from the remainder of lead 265 exposescontacts 262′. For example, after a trial procedure is performed withimplantable device 200 and lead 265 (e.g. in the condition shown in FIG.1C), distal portion 264 can be detached from the more proximal portionof lead 265 (and thus from implantable device 200), such that contacts262′ can be advanced into connector 890 of implantable device 800 suchthat contacts 262′ operably connect to contacts 890. In someembodiments, lead 265 comprises a sleeve, or other seal-creatingelement, surrounding the junction of distal portion 264 and theremaining (proximal) portion of lead 265, not shown but such as sleeve266 described hereabove in reference to FIG. 1B.

Referring now to FIG. 2 , a flow chart of a method of providingstimulation for an initial trial period, and a subsequent therapy periodis illustrated, consistent with the present inventive concepts. Themethod 2000 of FIG. 2 can be accomplished with apparatus 10 and any ofits components as described in reference to the associated figures, andwill be described using those components. STEPS 2100, 2200 and 2300represent a first clinical procedure (e.g. a surgery such as a minimallyinvasive surgery) performed on a patient to receive stimulation viaapparatus 10. In STEP 2100, lead 265 is implanted in the patient. InSTEP 2200, lead 265 is attached to one or more implantable stimulationdevices, such as when lead 265 is attached to implantable device 200 atattachment port 290. In STEP 2300, implantable device 200 is implantedin the patient. STEPs 2100, 2200 and 2300, can be performed in anyorder.

In STEP 2400, a trial period is performed in which implantable device200 delivers stimulation energy to the patient, such as to attempt toprovide pain relief or other therapy as described herein. During thetrial period of STEP 2400, stimulation can be provided in order toevaluate use of apparatus 10 to provide therapy to the patient, such asis described hereabove in reference to FIG. 1 . During the trial period,stimulation settings can be varied (e.g. variations of: stimulationelement 260 positions, configurations and/or combinations; stimulationfrequencies; stimulation waveform shapes; and/or stimulation pulsewidths and/or amplitudes), such as to optimize or at least improvetherapeutic benefit to the patient. The trial period of STEP 2400 canhave a duration of at least 1 week, at least 2 weeks, at least 1 month,at least 2 months, and/or at least 3 months. During the trialing period,implantable device 200 receives power and data from external system 50(e.g. from one or more external devices 500), as is described herein,avoiding the need for a large capacity energy storage assembly 270 (e.g.reducing the volume of implantable device 200).

STEPS 2500, 2600 and 2700 represent a second clinical procedure (e.g. asurgery such as a minimally invasive surgery) performed on the patient.In STEP 2500, lead 265 is disconnected from implantable device 200 (e.g.disconnected from attachment port 290), and implantable device 200 isexplanted from the patient. In STEP 2600, lead 265 is attached to one ormore other implantable stimulation devices, such as when lead 265 isattached to implantable device 800 at attachment port 890. In STEP 2700,implantable device 800 is implanted in the patient. STEPs 2500, 2600 and2700 can be performed in any order.

In STEP 2800, a therapy period is performed in which implantable device800 delivers stimulation energy to the patient, such as to provide painrelief or other therapy as described herein. Implantable device 800 canprovide long-term therapy to the patient for a therapy period of atleast 1 month, at least 6 months, at least 1 year and/or at least 2years. During the therapy period, implantable device 800 may not receiveany power from external system 50, such as when energy storage assembly870 comprises a capacity sufficient to deliver stimulation for theentire therapy period. In alternative embodiments, energy storageassembly 870 is recharged periodically (e.g. not continually), such asvia a wireless recharge (e.g. via a RF or other wireless transmitter,magnetic coupling, inductive coupling, capacitive coupling and/or otherwireless power transmission means).

In some embodiments, the therapy period of STEP 2800 is stopped due toone or more of: patient therapy is no longer needed; energy storageassembly 870 is depleted (e.g. after a period of at least 1 year);and/or an infection or other patient complication occurs. In theseembodiments, all or a portion of the method of FIG. 2 can be repeated,such as by returning to STEP 2100, 2200 or 2300, or returning directlyto STEP 2500, 2600 or 2700.

In some embodiments, after completion of STEP 2400, use of apparatus 10is stopped, such as when adequate therapeutic results are not achievedin STEP 2400 (e.g. despite various changes in stimulation parameters).Alternatively, after completion of STEP 2400, if adequate therapy isachieved, long-term therapy can continue to be provided by implantabledevice 200, without the need for the second clinical procedure of STEPs2500, 2600 and 2700 nor the use of a second implantable device such asimplantable device 800.

Referring now to FIG. 3 , a perspective view of an apparatus comprisinga temporary implantable device and an attachable lead for use in atrialing period is illustrated, consistent with the present inventiveconcepts. Apparatus 10 comprises implantable device 200, lead 265, andother components of similar construction and arrangement to thosedescribed hereabove in reference to FIG. 1 . Implantable device 200 ofFIG. 3 comprises a clam-shell shaped housing, housing 210′.

During a clinical procedure, the proximal portion 268 of lead 265 isinserted into attachment port 290 comprising two hinged portions (e.g.two flexible-hinge portions) of housing 210′ in a clam-shellarrangement. Housing 210′ is compressed to make electrical, optical,acoustic, mechanical and/or other operable connection with proximalportion 296 of lead 265, as well as sealingly surround proximal portion268, such that contacts 262 are maintained within housing 210′ and aseal (e.g. a temporary seal as described herein) is maintained to atleast temporarily prevent contamination from interfering with theconnection between contacts 262 and correspondingly aligned contacts 292of attachment port 290. Implantable device 200 can comprise one or moregaskets and/or other sealing material, gasket 296 shown, to assist increating the seal between lead 265 and implantable device 200.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 4A-B, top views of an apparatus comprising atemporary implantable device and an attachment lead for use in atrialing period is illustrated, consistent with the present inventiveconcepts. Implantable device 200 of FIGS. 4A-B is shown with the topportion of housing 210 removed for illustrative clarity. Apparatus 10comprises implantable device 200, lead 265, and other components ofsimilar construction and arrangement to those described hereabove inreference to FIG. 1 . Implantable device 200 of FIGS. 4A-B comprisesattachment port 290 which extends from the bottom to the top ofimplantable device 200, such as to receive the proximal portion of lead265 including all contacts 262.

Apparatus 10 can include tool 61, configured to slidingly engage andexpand (e.g. radially expand) attachment port 290, such that proximalportion 268 can be inserted into tool 61, while tool 61 is in placewithin attachment port 290, as shown in FIG. 4A. Radial expansion ofattachment port 290 can include expansion and/or displacement of one ormore of: housing 210; and/or one or more gaskets within attachment port290, gasket 296. Subsequently, tool 61 can be removed from attachmentport 290, such that attachment port 290 radially contracts, as shown inFIG. 4B. After removal of tool 61, seal 267 is created, such as atemporary seal as described herein. With tool 61 removed, contacts 262of lead 265 are operably connected (e.g. electrically, optically,mechanically, and/or acoustically connected) to contacts 292 ofattachment port 290, such as to create an operable connection with oneor more internal components of implantable assembly 200.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 5A-B, top views of an apparatus comprising atemporary implantable device and an attachment lead for use in atrialing period is illustrated, consistent with the present inventiveconcepts. Implantable device 200 of FIGS. 5A-B is shown with the topportion of housing 210 removed for illustrative clarity. Apparatus 10comprises implantable device 200, lead 265, and other components ofsimilar construction and arrangement to those described hereabove inreference to FIG. 1 . Implantable device 200 of FIGS. 5A-B comprisesattachment port 290 which extends from the bottom to the top ofimplantable device 200, such as to receive the proximal portion 268 oflead 265 including all contacts 262.

Implantable device 200 includes a connecting and inserting component,sleeve 297 a, configured to slidingly engage attachment port 290, suchthat proximal portion 268 can be positioned within sleeve 297 a whilesleeve 297 a is in place within attachment port 290. In someembodiments, sleeve 297 a is positioned within attachment port 290,after which lead 265 is inserted into sleeve 297 a. Alternatively, lead265 can be inserted into attachment port 290, after which sleeve 297 acan be inserted between lead 265 and attachment port 290. Sleeve 297 acomprises connecting segments 297 b (e.g. conductive material) which arepositioned to align with contacts 262 of lead 265 and contacts 292 ofattachment port 290, such as to provide an operable connection betweencontacts 262 and contacts 292 when lead 265 and sleeve 297 a are inplace within implantable device 200.

In some embodiments, sleeve 297 a further comprises a compressiblegasket, gasket 297 c. Gasket 297 c can be fixedly attached to sleeve 297a, or it can be a separate component as shown in FIG. 5A. In someembodiments, gasket 297 c is a separate component that is positionedabout proximal portion 268 of lead 265, after which it is inserted intosleeve 297 a (which is already positioned in attachment port 290) orinto attachment port 290 (after which sleeve 297 a is inserted). Gasket297 c comprises connecting segments 297 d (e.g. conductive material)which are positioned to align with connecting segments 297 b of sleeve297 a, contacts 262 of lead 265, and contacts 292 of attachment port290, such as to provide an operable connection between contacts 262 andcontacts 292 when lead 265, sleeve 297 a, and gasket 297 c are in placewithin implantable device 200 (as shown in FIG. 5B).

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 6A-C, a side view, a sectional view, and aperspective view, respectively, of an attachment port of an implantabledevice are illustrated, consistent with the present inventive concepts.Apparatus 10 comprises implantable device 200, lead 265, and othercomponents of similar construction and arrangement to those describedhereabove in reference to FIG. 1 . Implantable device 200 of FIGS. 6A-Ccomprises attachment port 290 which extends within implantable device200, such as to receive the proximal portion 268 of lead 265 includingall contacts 262. Attachment port 290 includes contacts 292′ comprisingfrictionally engaging contacts (e.g. brush-like contacts), such aselectromechanical brushes used in electrical motors or any other commonform of interference connector (e.g. canted springs, conductive mesh,deformable fingers, and the like). Contacts 292′ are each electricallyattached to one or more electrical components of implantable device 200,such as via electrical wires as shown. Attachment port 290 and contacts292′ are configured to slidingly receive and frictionally engageproximal portion 268 of lead 265, and to provide an electricalconnection between contacts 262 and one or more electrical-basedinternal components of implantable device 200. Attachment port 290 caninclude one or more gaskets, gasket 296 shown, to provide a seal aroundthe entry point of lead 265 into attachment port 290. Gasket 296 canalso include one or more gaskets positioned between each of the adjacentcontacts 292′, such as to minimize fluid conduction pathways betweencontacts 292′.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 7A-C, a side sectional view, a sectional view,and a perspective view, respectively, of an attachment port of animplantable device are illustrated, consistent with the presentinventive concepts. Apparatus 10 comprises implantable device 200, lead265, and other components of similar construction and arrangement tothose described hereabove in reference to FIG. 1 . Implantable device200 of FIGS. 7A-C comprises attachment port 290 which extends withinimplantable device 200, such as to receive the proximal portion 268 oflead 265 including all contacts 262. Attachment port 290 includesrotating contacts 292″, each (four shown) comprising a hinge, anextension arm, and a conductive pin. The conductive pin of contacts 292″are each electrically attached to one or more electrical components ofimplantable device 200, such as via electrical wires as shown.Attachment port 290 is configured to slidingly receive proximal portion268 of lead 265, after which contacts 292″ can be rotated such that itspins frictionally engage and electrically connect to contacts 262 oflead 265, providing an electrical connection between contacts 262 andone or more electrical-based internal components of implantable device200. The pins can pass through preformed holes (e.g. vias) and/orpuncture through housing 210 in order to make the connection. Attachmentport 290 can include one or more gaskets, gasket 296 shown, to provide aseal around the entry point of lead 265 into attachment port 290. Gasket296 can also include one or more gaskets positioned between each of thecontacts 292″ to minimize fluid conduction pathways between contacts292″.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 8A-C, a side view, a sectional view, and aperspective view, respectively, of an attachment port of an implantabledevice are illustrated, consistent with the present inventive concepts.Apparatus 10 comprises implantable device 200, lead 265, and othercomponents of similar construction and arrangement to those describedhereabove in reference to FIG. 1 . Implantable device 200 of FIGS. 8A-Ccomprises attachment port 290 which extends within implantable device200, such as to receive the proximal portion 268 of lead 265 includingall contacts 262. Attachment port 290 includes spring-loaded contacts292′″, each (four shown) comprising a conductive pin and a spring-likecomponent configured to bias the pin in an extended position, as shownin FIG. 8B. The conductive pin of contacts 292′″ are each electricallyattached to one or more electrical components of implantable device 200,such as via electrical wires as shown.

Attachment port 290 and contacts 292′″ are configured to slidinglyreceive proximal portion 268 of lead 265. Once fully inserted, contacts292′″ frictionally engage and electrically connect to contacts 262 oflead 265, providing an electrical connection between contacts 262 andone or more electrical-based internal components of implantable device200. Attachment port 290 can include one or more gaskets, gasket 296shown, to provide a seal around the entry point of lead 265 intoattachment port 290. Gasket 296 can also include one or more gasketspositioned between each of the contacts 292′″ to minimize fluidconduction pathways between contacts 292′″.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 9A-B, a side sectional view, and an end view,respectively, of an implantable device are illustrated, consistent withthe present inventive concepts. Implantable device 200, lead 265, andother components of apparatus 10 can be of similar construction andarrangement to those described hereabove in reference to FIG. 1 .Implantable device 200 of FIGS. 9 A-B comprises attachment port 290which extends within implantable device 200, such as to receive theproximal portion of a lead 265 including all contacts 262 (not shown).Attachment port 290 includes spring-loaded contacts 292, each (fourshown) comprising a conductive segment electrically attached to one ormore electrical components of implantable device 200, such as viaelectrical wires as shown.

Attachment port 290 and contacts 292 are configured to slidingly receiveproximal portion 268 of lead 265. Once fully inserted, contacts 292frictionally engage and electrically connect to contacts 262 of lead265, providing an electrical connection between contacts 262 and one ormore electrical-based internal components of implantable device 200.Contacts 262 can be of similar construction and arrangement to any ofcontacts 292′, 292″ and/or 292′″ described herein. Attachment port 290further comprises compression element 293 which can be configured tocompress (e.g. radially compress) attachment port 290 onto lead 265,such as to provide a seal at the location in which lead 265 entersattachment port 290. Alternatively or additionally, compression element293 can be configured to create and/or improve the connection betweencontacts 262 and contacts 292. In some embodiments, attachment port 290includes one or more gaskets, gasket 296 shown, to provide and/orenhance the seal between lead 265 and attachment port 290. Gasket 296can also include one or more gaskets positioned between each of thecontacts 292 to minimize fluid conduction pathways between contacts 292.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 10A-B, perspective views of an implantable deviceprior to and after attachment to a lead, respectively, are illustrated,the implantable device comprising a rollable construction forsurrounding the lead, consistent with the present inventive concepts.Implantable device 200 and lead 265 can be of similar construction andarrangement to those described hereabove in reference to FIG. 1 .Implantable device 200 of FIGS. 10A-B comprises a flexible housing,housing 210″, which is configured to be rolled such that housing 210″circumferentially surrounds lead 265 as shown in FIG. 10B, where housing210″ circumferentially surrounds lead 265. Housing 210″ can comprise aflexible material and/or it can comprise multiple hinged sectionsconfigured to be pivoted (i.e. flexed) at each hinge section.

Implantable device 200 comprises contacts 292 (four shown) which areconfigured to operatively connect to corresponding contacts 262 (fourshown) of lead 265, such as to provide an electrical connection betweencontacts 262 and one or more electrical-based internal components ofimplantable device 200. Contacts 262 can be of similar construction andarrangement to any of contacts 292′, 292″ and/or 292′″ described herein.In some embodiments, housing 210″ comprises an adhesive portion, portion211 shown on the top side of housing 210″, which can be configured tomaintain housing 210″ about lead 265 (e.g. prevent unrolling of housing210″).

In some embodiments, attachment port 290 includes one or more gaskets,such as gasket 296 shown, to provide and/or enhance the seal betweenlead 265 and attachment port 290. Gasket 296 can also include one ormore gaskets positioned between each of the contacts 292 to minimizefluid conduction pathways between contacts 292.

In some embodiments, lead 265 is configured to be detached fromimplantable device 200 and subsequently operatively attached toimplantable device 800 (e.g. in a second clinical procedure in whichimplantable device 800 is implanted). In some embodiments, lead 265comprises a removable distal portion configured to subsequently attachto second implantable stimulator 800, as described hereabove inreference to FIG. 1C.

Referring now to FIGS. 11A-D, perspective views of various embodimentsof a distal portion of a stimulation lead are illustrated, consistentwith the present inventive concepts. Lead 265 can comprise chronicallyimplantable lead, such as a lead configured to provide long term therapy(e.g. a lead implanted for at least one week, at least one month, and/orat least 6 months), and/or a test lead configured to be inserted in thepatient for an acute period of time (e.g. to provide temporarystimulation for less than one hour, less than one day, and/or less thanone week). For example, lead 265 can comprise a needle-likeconstruction, with the distal portion 269 constructed and arrange to betemporarily inserted proximate one or more nerves to be stimulated bystimulation apparatus 10, as described herein. In some embodiments,after implantation and/or while temporarily inserted, lead 265 can beused in a trialing procedure as described herebelow in reference to FIG.13 .

As described herebelow, lead 265 can comprise various configurations,such as varied constructions of its distal portion, such as distalportions 2691-2694 shown. The distal portions can each include one ormore stimulation elements 260 configured to deliver energy to targettissue of a patient (e.g. one or more electrodes configured to delivermonopolar or bipolar electrical energy to tissue). Each lead 265 cancomprise a proximal portion, such as proximal portions 2681-2683 asdescribed herebelow in reference to FIGS. 12A-C, or other proximalportion 268 described herein. The proximal portion of each lead 265 caninclude one or more contacts 262 configured to operably connect to astimulation device (e.g. to provide an electrical connection betweenstimulation device 200/800 and one or more stimulation elements 260 suchthat energy provided by the stimulation device can be delivered by thestimulation elements 260).

As shown in FIG. 11A, distal portion 2691 can comprise a flex circuit2631 and a covering surrounding flex circuit 2631, overmold 2611. Insome embodiments, one or more portions of overmold 2611 are removed(e.g. via a manufacturing process) to create one or more recesses 2612to expose stimulation elements 260 configured to deliver energy totarget tissue. Flex circuit 2631 can comprise one or more traces 2632extending from the proximal portion of lead 265 to distal portion 2691of lead 265. Traces 2632 can operably connect stimulation elements 260and contacts 262 (e.g. to provide an electrical connection betweenstimulation elements 260 and contacts 262).

As shown in FIG. 11B, distal portion 2692 can comprise a conductive rod2633 (e.g. a needle) with layer stack 2634 applied thereon (e.g.multiple layers applied to rod 2633). Layer stack 2634 can comprisealternating layers of an insulator 2635 and a conductor 2636, with theouter most layer comprising insulator 2635. The layers of insulator 2635and conductor 2636 can be applied using one or more of the followingdeposition processes: sputtering; evaporation; dipping; plating;spraying; and chemical vapor deposition (CVD). In some embodiments, oneor more portions of layer stack 2634 are removed (e.g. via amanufacturing process, such as laser ablation, wet etch, lift-off, etc.)to create one or more recesses 2612 to expose one or more portions ofconductor 2636 and/or conductive rod 2633. The exposed portions ofconductor 2633 and/or conductive rod 2636 can comprise metalizedcontacts, stimulation elements 260 that are configured to deliver energyto target tissue. Conductive rod 2633 and/or conductor 2636 can operablyconnect to contacts 262 (e.g. to provide an electrical connectionbetween stimulation elements 260 and contacts 262).

As shown in FIG. 11C, distal portion 2693 can comprise one or morelumens 2613 extending from the proximal portion of lead 265 to distalportion 2693 of lead 265. Lumens 2613 can surround one or more wires2637 that operably connect stimulation elements 260 and contacts 262(e.g. to provide an electrical connection between stimulation elements260 and contacts 262).

As shown in FIG. 11D, distal portion 2694 can comprise a needle-likeconstruction, including (e.g. surrounding) one or more wires 2637extending from proximal portion 268 to distal portion 2694 of lead 265.Wires 2637 can operably connect stimulation elements 260 and contacts262 (e.g. to provide an electrical connection between stimulationelements 260 and contacts 262).

Referring now to FIGS. 12A-C, side views of various embodiments of aproximal portion of a stimulation lead are illustrated, consistent withthe present inventive concepts. Lead 265 can comprise a chronicallyimplantable lead, as described herein, and/or a test lead configured tobe inserted in the patient for an acute period of time, as describedherein. For example, lead 265 can comprise a needle-like construction,with its distal portion 269 constructed and arranged to be temporarilyinserted proximate one or more nerves to be stimulated by stimulationapparatus 10, as described herein. In some embodiments, afterimplantation and/or while temporarily inserted, lead 265 can be used ina trialing procedure as described herebelow in reference to FIG. 13 .

As described herebelow, lead 265 can comprise various configurations,such as varied constructions of its proximal portion, such as proximalportions 2681-2683 as shown. The proximal portions can each include oneor more contacts 262 configured to operably connect to a stimulationdevice (e.g. to provide an electrical connection between stimulationdevice 200/800 and one or more stimulation elements 260 such that energyprovided by the stimulation device can be delivered by the stimulationelements 260). Each lead 265 can comprise a distal portion 269, such asdistal portions 2691-2694 as described hereabove in reference to FIGS.11A-C, or other distal portions 269 described herein. Distal portion 269can include one or more stimulation elements 260 configured to deliverenergy to target tissue of a patient (e.g. one or more electrodesconfigured to deliver monopolar or bipolar electrical energy).

As shown in FIG. 12A, proximal portion 2681 can comprise one or morecontacts 2621. Contacts 2621 can be operably attached to conduit 263.Contacts 2621 can each comprise a length of at least 0.07 inches. Insome embodiments, contacts 2621 comprise a length greater than thelength of contacts of commercially available stimulation leads, and/orcontacts 2621 are otherwise sized such that a user can securely,repeatably, and/or reliably attach an alligator clip and/or otherconnection device to contact 2621 (e g minimizing the likelihood ofconnecting to an undesired contact of the lead).

A shown in FIG. 12B, proximal portion 2682 can comprise one or morecontacts 262 operably attached to conduit 263. Proximal end 2682 can beoperably insertable into a connector, such as attachment port 290 and/or890 as described herein. Alternatively or additionally, proximal end2682 can be operably attachable to an attachment mechanism, such asdescribed herebelow in reference to FIGS. 15A-E.

As shown in FIG. 12C, proximal portion 2683 can comprise one or morecontacts 262 that are operably attached to one or more connectors 2622.Each connector 2622 can comprise an alligator clip or otherelectrically-connecting element.

Referring now to FIG. 13 , a flow chart of a method of providingstimulation during a trialing procedure is illustrated, consistent withthe present inventive concepts. The trialing procedure comprising method3000 of FIG. 13 can be accomplished with a stimulation device (e.g.stimulation device 200/800 described herein) and an implantable lead265. In STEP 3100, lead 265 is implanted in the patient. In STEP 3200, astimulation device is connected to a first contact 262 of lead 265. Atrial period is initiated during which the stimulation device deliversstimulation energy with a minimum stimulation signal (e.g. a stimulationlevel at or close to 0). During STEP 3300, the stimulation signal isincreased, such as to achieve an optimized, or at least an improved,therapeutic benefit to the patient (e.g. increased pain relief). In STEP3400, once a desired therapeutic benefit is achieved (or a maximumstimulation level is reached with or without achieving a desiredtherapeutic benefit), the stimulation signal is decreased to the minimumstimulation signal. In STEP 3500, the stimulation device is disconnectedfrom the first contact 262 and subsequently connected to a secondcontact 262. A trial period is initiated during which the stimulatordelivers stimulation energy with the minimum stimulation signal. STEPS3300 through 3500 can be repeated with additional contacts 262 toachieve an optimized therapeutic benefit to the patient.

After completion of STEP 3400 for the final contact 262 (e.g. eachcontact 262 has delivered trialing stimulation), if adequate therapy isachieved (e.g. an optimized, desired, and/or otherwise adequate therapyis achieved), long-term therapy can be implemented with implantabledevice 200/800 and lead 265 using the optimized stimulation signalsidentified in method 3000.

Referring now to FIGS. 14A-D, side views of an implantable systemcomprising a short-term (temporary) implantable device with anintegrated lead, and a lead removal tool are illustrated, consistentwith the present inventive concepts. The lead removal tool is used toremove the lead from the short-term implantable device for subsequentuse with a long-term implantable device. The short-term implantabledevice can comprise implantable device 200, as described hereabove, suchas to provide temporary stimulation therapy, as described hereabove. Thelong-term implantable device can comprise implantable device 800, suchas to provide long-term stimulation therapy to the patient, also asdescribed hereabove.

As shown in FIG. 14A, implantable device 200 and lead 265 are integrated(e.g. lead 265 is fixedly attached to implantable device 200, such asduring a manufacturing process). Implantable device 200 can be operablyattached via one or more wires 294 to one or more stimulation elements260 of lead 265. Lead 265 comprises one or more contacts 262 which aresimilarly connected to stimulation elements 260. Contacts 262 can becovered by an insulating material, insulator 66, which can comprise apassivation layer applied to contacts 262 and/or an insulating sleeve.In some embodiments, implantable device 200 and lead 265 are operablyattached via connector 66. Insulator 66 can extend from the mostproximal contact 262 to the most distal contact 262. Insulator 66 can beconfigured to be removed, such as via a peeling process, to exposecontacts 262, as described herebelow.

As shown in FIG. 14B, a tool 62 can slidingly receive implantable device200 through an opening 63. In some embodiments, opening 63 can includeone or more projections 64. Projections 64 can be configured to engagelead 265 at a pre-determined location, as indicated by a marker 68 onproximal portion 268 of lead 265. In some embodiments, marker 68 ispositioned at a weakened portion of lead 265.

As shown in FIG. 14C, in response to an external force, projections 64can travel inward and frictionally engage lead 265 at marker 68, toseparate lead 265 from implantable device 200 (e.g. to sever and/orcause a break in lead 265). In some embodiments, insulator 66 is removedto expose contacts 262. Implantable device 200 (e.g. including a portionof wires 294), can be removed and replaced with implantable device 800,as shown in FIG. 14D. Implantable device 800 can slidingly receive theproximal portion (e.g. the remaining proximal portion) of lead 265,including contacts 262 (e.g. lead proximal portion 268). Contacts 262each align with and operably engage associated contacts 892 of device800, similar to as described hereabove in reference to FIG. 1 .

Referring now to FIGS. 15A-E, a perspective view of a stimulator and alead attachment assembly, and various close-up views of an attachmentmechanism of the attachment assembly, are illustrated, consistent withthe present inventive concepts. Attachment assembly 650 can comprise anattachment mechanism 655, and can be used to attach a lead 265 to astimulation device 600. Stimulation device 600 can be configured toprovide stimulation energy to lead 265 (similar to implantable devices200/800), and it can include a user interface (e.g. similar to devices500/550). In some embodiments, stimulation device 600 receives commands(e.g. wirelessly receives commands) from devices 500/550.

As shown in FIG. 15A, stimulator device 600 can include a conduit 601(e.g. a conduit including one or more wires) with a distal endconnector, connector 602. Attachment assembly 650 can include a conduit651 with a proximal end connector, connector 652. In some embodiments,connectors 602,652 comprise pig-tail connectors configured to operablyconnect stimulation device 600 and attachment assembly 650. Attachmentassembly 650 can comprise an attachment mechanism 655 with a baseportion, base 656, and one or more hinged portions, clip 657.

Base 656 can include one or more contacts 659 operably connected toconduit 651 (e.g. to provide an electrical connection between wires ofconduit 651 and contacts 659). Base 656 can slidingly receive and/orrotatably engage a portion of clip 657, such that attachment mechanism655 can transition from an open configuration (as shown in FIGS. 15D andE) to a closed configuration (as shown in FIGS. 15B and C).

As shown in FIG. 15B, clip 657 can comprise a first recess 658configured to slidingly receive a portion of lead 265, includingcontacts 262. In the closed configuration, contacts 659 can extend intorecess 658 and operably connect (e.g. at least electrically connect) tocontacts 262 of an inserted lead 265 (e.g. to provide at least anelectrical connection between contacts 262 and 659). For example, lead265 can be inserted into recess 658 when attachment mechanism is in anopen configuration, and clip 657 can subsequently be “closed”, lockinglead 265 within recess 658, allowing contacts 262 and 659 to operablyengage.

As shown in FIGS. 15C and D, attachment mechanism 655 can transitionbetween an open configuration and a closed configuration (the openconfiguration shown in FIG. 15D). Base 656 and clip 657 can beconfigured to interlock (e.g. releasably interlock) in the closedconfiguration, thereby securing a portion lead 265 within attachmentmechanism 655. Base 656 can include a projection 6561 configured tofrictionally engage a second recess 6562 of clip 657. In someembodiments, attachment mechanism transitions from the openconfiguration to the closed configuration when clip 657 is depressed bya user (e.g. projection 6561 engages recess 6562). In other embodiments,attachment mechanism 655 transitions from the closed configuration tothe open configuration when clip 657 is elevated by a user (e.g.projection 6561 disengages from recess 6562 when clip 657 is lifted awayfrom base 656).

As shown in FIG. 15E, clip 657 can be configured to abut another portionof attachment mechanism 655, such as to limit the elevation of clip 657relative to base 656. In some embodiments, attachment assembly 650 cancomprise a functional element 699. Functional element 699 can comprise asensor, configured to detect a proper (or improper) connection of a lead265 to attachment mechanism 655 (e.g. via an impedance measurement).Additionally or alternatively, functional element 699 can comprise atransducer, such as a speaker. For example, functional element can beconfigured to alert the user via an audible alarm if lead 265 isdislodged from attachment mechanism 655. In some embodiments, stimulator600 comprises functional element 699.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the present inventiveconcepts. Modification or combinations of the above-describedassemblies, other embodiments, configurations, and methods for carryingout the invention, and variations of aspects of the invention that areobvious to those of skill in the art are intended to be within the scopeof the claims. In addition, where this application has listed the stepsof a method or procedure in a specific order, it may be possible, oreven expedient in certain circumstances, to change the order in whichsome steps are performed, and it is intended that the particular stepsof the method or procedure claim set forth herebelow not be construed asbeing order-specific unless such order specificity is expressly statedin the claim.

We claim:
 1. A method of applying stimulation therapy to a patient, themethod comprising: implanting at least one lead under the skin of thepatient, the at least one implanted lead comprising at least onestimulation element configured to deliver stimulation energy to tissueof the patient; implanting a first implantable device in a patient andattaching the first implantable device to the at least one implantedlead, wherein the first implantable device is configured to deliver afirst stimulation energy to the at least one stimulation element of theat least one implanted lead for a first time period; detaching the atleast one implanted lead from the first implantable device after thefirst time period; and implanting a second implantable device andattaching the second implantable device to the at least one implantedlead, wherein the second implantable device is configured to deliver asecond stimulation energy to the at least one stimulation element of theat least one implanted lead for a second time period, subsequent to thefirst time period, and wherein the second time period is a longer periodof time than the first time period.
 2. The method according to claim 1,wherein the first period is less than or equal to 3 months.
 3. Themethod according to claim 1, wherein the second time period is greaterthan or equal to 3 months.
 4. The method according to claim 1, whereinattaching the first implantable device to the at least one implantedlead comprises operably connecting a first implantable connector of thefirst implantable device to the at least one implanted lead, whereinattaching the second implantable device to the at least one implantedlead comprises operably connecting a second implantable connector of thesecond implantable device to the at least one implanted lead, andwherein the first implantable connector and the second implantableconnector comprise dissimilar construction and arrangement.
 5. Themethod according to claim 4, wherein the first implantable connector isconfigured to provide a contamination-preventing seal for a limited timeperiod, and wherein the second implantable connector is configured toprovide a contamination-preventing seal for an extended time period. 6.The method according to claim 5, wherein the limited time periodcomprises less than 3 months, and wherein the extended time periodcomprises more than 3 months.
 7. The method according to claim 1,wherein the at least one implanted lead is integrated into the firstimplantable device.
 8. The method according to claim 7, furthercomprising detaching the at least one implanted lead from the firstimplantable device.
 9. The method according to claim 8, whereindetaching the at least one implanted lead from the first implantabledevice comprises severing and/or breaking the at least one implantedlead.
 10. The method according to claim 9, further comprising attachingthe at least one implanted lead to the second implantable device afterdetaching the at least one implanted lead from the first implantabledevice.
 11. The method according to claim 1, wherein the at least oneimplanted lead comprises a proximal portion and a distal portion, andfurther comprising detaching the distal portion from the proximalportion.
 12. The method according to claim 11, wherein attaching thesecond implantable device to the at least one implanted lead comprisesoperably connecting a second implantable connector of the secondimplantable device to the at least one implanted lead, and wherein themethod further comprises attaching the detachable distal portion to thesecond implantable connector.
 13. The method according to claim 11,wherein the proximal portion is pre-attached to the first implantabledevice.
 14. The method according to claim 1, wherein the firstimplantable device receives power and data from an external system, andwherein the second implantable device receives data from the externalsystem.
 15. The method according to claim 14, wherein the secondimplantable device does not receive power from the external system. 16.The method according to claim 14, wherein the external system isconfigured to transmit transmission signals and comprises a firstexternal device comprising: at least one external antenna configured totransmit the transmission signals to one or more of the first or secondimplantable devices; an external transmitter configured to drive the atleast one external antenna; an external power supply configured toprovide power to at least the external transmitter; and an externalcontroller configured to control the external transmitter.
 17. Themethod according to claim 1, wherein the first implantable devicecomprises an implantable energy storage assembly.
 18. The methodaccording to claim 17, wherein the implantable energy storage assemblyof the second implantable device has a greater energy storage capacitythan the implantable energy storage assembly of the first implantabledevice.
 19. The method according to claim 18, wherein the implantableenergy storage assembly of the second implantable device has at least 10times the energy storage capacity as the energy storage capacity of theimplantable energy storage assembly of the first implantable device. 20.The method according to claim 17, wherein the first implantable deviceenergy storage assembly comprises an energy storage capacity of no morethan 40 Joules.
 21. The method according to claim 20, wherein the secondimplantable device energy storage assembly comprises an energy storagecapacity of at least 60 Joules.
 22. The method according to claim 1,wherein the first implantable device is configured to deliverstimulation energy to the at least one stimulation element of theimplanted lead and comprises: at least one first implantable antennaconfigured to receive a transmission signal from an external system, thetransmission signals comprising power and data; a first implantablereceiver configured to receive the transmission signals from the atleast one first implantable antenna; a first implantable controllerconfigured to deliver energy to the at least one stimulation element ofthe implanted lead, the delivered energy provided by the transmissionsignals received from the external device; and a first implantablehousing surrounding at least the first implantable controller and thefirst implantable receiver.
 23. The method according to claim 1, whereinthe second implantable device is configured to deliver stimulationenergy to the at least one stimulation element of the implanted lead andcomprises: at least one second implantable antenna configured to receivea transmission signal from an external system, the transmission signalscomprising data; a second implantable receiver configured to receive thetransmission signals from the at least one second implantable antenna;an implantable energy storage assembly comprising a battery and/or acapacitor; a second implantable controller configured to deliver energyto the at least one stimulation element of the implantable lead, thedelivered energy provided by the implantable energy storage assembly;and a second implantable housing surrounding at least the secondimplantable controller and the second implantable receiver.
 24. A methodof applying stimulation therapy to a patient, the method comprising:attaching a first implantable device implanted in a patient to at leastone lead implanted in the patient; delivering a first stimulation energyto at least one stimulation element of the at least one implanted leadwith the first implantable device implanted in the patient and attachedto the at least one implanted lead, wherein the first stimulation energyis delivered to the at least one stimulation element for a first timeperiod; detaching the at least one implanted lead from the firstimplantable device after the first time period; attaching a secondimplantable device implanted in the patient to the at least oneimplanted lead; delivering a second stimulation energy to the at leastone stimulation element of the at least one implanted lead with thesecond implantable device implanted in the patient and attached to theat least one implanted lead, wherein the second stimulation energy isdelivered to the at least one stimulation element for a second timeperiod, and wherein the second time period is a longer period of timethan the first time period.
 25. The method according to claim 24,wherein the first period is less than or equal to 3 months.
 26. Themethod according to claim 24, wherein the second time period is greaterthan or equal to 3 months.
 27. The method according to claim 24, whereinattaching the first implantable device to the at least one implantedlead comprises operably connecting a first implantable connector of thefirst implantable device to the at least one implanted lead, whereinattaching the second implantable device to the at least one implantedlead comprises operably connecting a second implantable connector of thesecond implantable device to the at least one implanted lead, andwherein the first implantable connector and the second implantableconnector comprise dissimilar construction and arrangement.
 28. Themethod according to claim 27, wherein the first implantable connector isconfigured to provide a contamination-preventing seal for a limited timeperiod, and wherein the second implantable connector is configured toprovide a contamination-preventing seal for an extended time period. 29.The method according to claim 28, wherein the limited time periodcomprises less than 3 months, and wherein the extended time periodcomprises more than 3 months.
 30. The method according to claim 24,wherein the at least one implanted lead is integrated into the firstimplantable device.
 31. The method according to claim 24, whereindetaching the at least one implanted lead from the first implantabledevice comprises severing and/or breaking the at least one implantedlead.
 32. The method according to claim 24, wherein the at least oneimplanted lead comprises a proximal portion and a distal portion, andfurther comprising detaching the distal portion from the proximalportion.
 33. The method according to claim 32, wherein attaching thesecond implantable device to the at least one implanted lead comprisesoperably connecting a second implantable connector of the secondimplantable device to the at least one implanted lead, and wherein themethod further comprises attaching the detachable distal portion to thesecond implantable connector.
 34. The method according to claim 32,wherein the proximal portion is pre-attached to the first implantabledevice.
 35. The method according to claim 24, further comprisingreceiving power and data from an external system with the firstimplantable device and receiving data from the external system with thesecond implantable device.
 36. The method according to claim 35, whereinthe second implantable device does not receive power from the externalsystem.
 37. The method according to claim 35, wherein the externalsystem is configured to transmit transmission signals and comprises afirst external device comprising: at least one external antennaconfigured to transmit the transmission signals to one or more of thefirst or second implantable devices; an external transmitter configuredto drive the at least one external antenna; an external power supplyconfigured to provide power to at least the external transmitter; and anexternal controller configured to control the external transmitter. 38.The method according to claim 37, wherein the first implantable devicecomprises an implantable energy storage assembly.
 39. The methodaccording to claim 38, wherein the implantable energy storage assemblyof the second implantable device has a greater energy storage capacitythan the implantable energy storage assembly of the first implantabledevice.
 40. The method according to claim 39, wherein the implantableenergy storage assembly of the second implantable device has at least 10times the energy storage capacity as the energy storage capacity of theimplantable energy storage assembly of the first implantable device. 41.The method according to claim 38, wherein the first implantable deviceenergy storage assembly comprises an energy storage capacity of no morethan 40 Joules.
 42. The method according to claim 41, wherein the secondimplantable device energy storage assembly comprises an energy storagecapacity of at least 60 Joules.
 43. The method according to claim 24,wherein the first implantable device is configured to deliverstimulation energy to the at least one stimulation element of theimplanted lead and comprises: at least one first implantable antennaconfigured to receive a transmission signal from an external system, thetransmission signals comprising power and data; a first implantablereceiver configured to receive the transmission signals from the atleast one first implantable antenna; a first implantable controllerconfigured to deliver energy to the at least one stimulation element ofthe implanted lead, the delivered energy provided by the transmissionsignals received from the external device; and a first implantablehousing surrounding at least the first implantable controller and thefirst implantable receiver.
 44. The method according to claim 24,wherein the second implantable device is configured to deliverstimulation energy to the at least one stimulation element of theimplanted lead and comprises: at least one second implantable antennaconfigured to receive a transmission signal from an external system, thetransmission signals comprising data; a second implantable receiverconfigured to receive the transmission signals from the at least onesecond implantable antenna; an implantable energy storage assemblycomprising a battery and/or a capacitor; a second implantable controllerconfigured to deliver energy to the at least one stimulation element ofthe implantable lead, the delivered energy provided by the implantableenergy storage assembly; and a second implantable housing surrounding atleast the second implantable controller and the second implantablereceiver.